The Recall Desk

Archive

November 2016 recalls

802 recalls were announced in November 2016.

What the numbers show

Critical
61
Severe
132
High
403
Moderate
173
Low
33

Of the 802 recalls this month scored against our rubric, 8% are Critical, 16% are Severe.

Which agencies issued them

201–300 of 802

  • HighFDA (Devices)·Z-0423-2017·2016-11-23

    ICU Medical Recalls Transpac IV Transducers Due to Leak Risk

    ICU Medical is recalling 4,580 units of Transpac IV Disposable Transducers with Stopcocks due to a potential leak in the SafeSet Reservoir and blood sampling kits.

    Product
    TRANSPAC¿ IV DISPOSABLE TRANSDUCER WITH STOPCOCKS, Item No. 42582-06 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0471-2017·2016-11-23

    ICU Medical Recalls Transpac Pressure Transducers Due to Potential Leak

    ICU Medical is recalling 336 units of Transpac pressure transducers and SafeSet reservoirs due to a potential for leak.

    Product
    LEFT HEART KIT FOR PORTLAND ADVENTIST HOSP., Item No. 46066-13 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0415-2017·2016-11-23

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 60,560 Transpac IV Monitoring Kits because of a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    TRANSPAC¿ IV MONITORING KIT, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP, Item No. 011-42584-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0469-2017·2016-11-23

    ICU Medical Recalls Transpac Transducer Kits Due to Leak Risk

    ICU Medical is recalling 175 Transpac transducer kits with SafeSet Reservoirs due to a potential leak hazard.

    Product
    ICN TRANSDUCER KIT W/30ML FLUSH DEVICE FOR STANFORD UNIV. HOSP., Item No. 46065-64 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0539-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir and Blood Sampling Kits

    ICU Medical is recalling SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    5 Port "OFF" Manifold w/TRANSPAC¿ IV, Item No. 46100-29 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0559-2017·2016-11-23

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 275 Transpac IV Monitoring Kits because of a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    Transpac¿ IV Monitoring Kit w/03 ml Squeeze Flush Device, Arterial Safeset" Reservoir and Needleless Valves, Item No. 46112-03 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0451-2017·2016-11-23

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 1,100 Transpac IV Monitoring Kits with SafeSet Reservoirs due to a potential leak. The kits were distributed nationwide.

    Product
    TRANSPAC¿ IV MONITORING KIT WITH SAFESET" RESERVOIR AND 2 BLOOD SAMPLING PORTS, 60" TUBING, DISPOSABLE TRANSDUCER, 3 ML INTRAFLO¿ FLUSH, MACRODRIP (POLE MOUNT), Item No. 42645-06 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0506-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak

    ICU Medical is recalling 144 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    TRIPLE PRESSURE KIT W/03ML FLUSH DEVICE FOR UNIV. OF IOWA, Item No. 46091-56 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0479-2017·2016-11-23

    ICU Medical Recalls Transpac Pressure Transducers Due to Leak Risk

    ICU Medical is recalling 20 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    RIGHT HEART CATH LAB KIT FOR BAPTIST MEM. HOSP., Item No. 46071-40 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0482-2017·2016-11-23

    ICU Medical Recalls Transpac IV Transducer Kits Due to Leak Risk

    ICU Medical is recalling 70 units of Transpac IV transducer kits due to a potential leak. The devices are used for blood sampling and pressure monitoring.

    Product
    MONITORING KIT W/03ML FLUSH DEVICE FOR PITT CO. MEM. HOSP., Item No. 46076-19 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0495-2017·2016-11-23

    ICU Medical Recalls Transpac Pressure Transducers Due to Leak Risk

    ICU Medical is recalling 660 Transpac pressure transducers and SafeSet reservoir kits due to a potential leak hazard.

    Product
    ADD-ON DISP. TRANSDUCER W/03ML FLUSH DEVICE FOR JOHNS HOPKINS HOSP., Item No. 46086-21 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0603-2017·2016-11-23

    Siemens AXIOM Artis Angiographic X-ray Systems Recalled for Footswitch Defect

    Siemens is recalling AXIOM Artis angiographic x-ray systems because the semi-automatic focus switch may fail when the footswitch is pressed multiple times.

    Product
    AXIOM Artis, Angiographic x-ray system Product Usage: The Artis systems are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0429-2017·2016-11-23

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling specific Transpac IV Monitoring Kits because of a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    Transpac¿ IV Monitoring Kit, 84", Disposable Transducer, 3 ml Squeeze Flush, Macrodrip, Item No. 42585-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0425-2017·2016-11-23

    ICU Medical Recalls Transpac IV Transducer Kits Due to Leak Risk

    ICU Medical is recalling 520 Transpac IV transducer kits because of a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    TRANSPAC¿ IV DISPOSABLE TRANSDUCER MONITORING KIT WITH BONDED STOPCOCK AND 3mL SQUEEZE FLUSH, Item No. 42582-09 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0493-2017·2016-11-23

    ICU Medical Recalls Transpac Pressure Transducer Kits Due to Leak Risk

    ICU Medical is recalling 20 units of Transpac pressure transducer kits due to a potential leak in the SafeSet Reservoir system.

    Product
    MONITORING KIT WITH 03ML FLUSH DEVICE FOR UNIV. OF NEW MEXICO, Item No. 46085-50 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0430-2017·2016-11-23

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 800 units of Transpac IV Monitoring Kits due to a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    TRANSPAC¿ IV MONITORING KIT NEONATAL, 24", DISPOSABLE TRANSDUCER, 30 ML SQUEEZE FLUSH (INFUSION PUMP), Item No. 42586-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0436-2017·2016-11-23

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Potential

    ICU Medical is recalling 40 units of Transpac IV Monitoring Kits due to a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    Transpac¿ IV Monitoring Kit w/4 Way Stopcock, 3 Way Stopcock and 24" Arterial Pressure Tubing, Item No. 42594-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0472-2017·2016-11-23

    ICU Medical Recalls Transpac Pressure Transducers Due to Leak Risk

    ICU Medical is recalling 125 Transpac pressure transducer kits due to a potential leak in the SafeSet Reservoir system.

    Product
    RIGHT HEART KIT FOR NC BAPTIST HOSPITAL, Item No. 46066-34 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0448-2017·2016-11-23

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 200 units of Transpac IV Monitoring Kits with SafeSet Reservoirs due to a potential for leaks.

    Product
    TRANSPAC¿ IV MONITORING KIT WITH SAFESET" RESERVOIR AND BLOOD SAMPLING PORT, 84" TUBING, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42643-06 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0536-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak

    ICU Medical is recalling 20 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    Quad Kit W/03ML Flush Device, Mounts, Reservoir & TP4, Item No. 46099-24 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0418-2017·2016-11-23

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 260 units of Transpac IV Monitoring Kits because of a potential for leaks in the SafeSet Reservoir and blood sampling components.

    Product
    TRANSPAC¿ IV MONITORING KIT WITH 2 BONDED STOPCOCKS, 72", DISPOSABLE TRANSDUCER WITH 2 BONDED STOPCOCKS, 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42500-02 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0463-2017·2016-11-23

    ICU Medical Recalls Transpac IV Transducer Kits Due to Leak Risk

    ICU Medical is recalling 100 units of Transpac IV transducer kits due to a potential leak. The affected items were distributed nationwide.

    Product
    DOUBLE LINE KIT WITH 03ML FLUSH DEVICE FOR UNIVERSITY OF MICHIGAN HOSP., Item No. 46063-03 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0468-2017·2016-11-23

    ICU Medical Recalls Transpac Pressure Transducers Due to Leak Risk

    ICU Medical is recalling 130 units of Transpac IV transducers and SafeSet Reservoir kits due to a potential leak.

    Product
    TRIPLE ANESTHESIA KIT W/03ML FLUSH DEVICE FOR JACKSON MEM. HOSP., Item No. 46064-54 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0557-2017·2016-11-23

    ICU Medical Recalls Transpac IV Transducers Due to Potential Leak

    ICU Medical is recalling 10 units of Transpac IV transducers with SafeSet Reservoirs due to a potential for leak.

    Product
    Trifurcated Transpac¿ IV w/03 ml Squeeze Flush Device, 130" Safeset" Reservoir and Needleless Valve, Item No. 46108-36 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0420-2017·2016-11-23

    ICU Medical Recalls Transpac IV Bifurcated Kits Due to Leak Risk

    ICU Medical is recalling 340 units of Transpac IV Bifurcated Kits with SafeSet Reservoirs due to a potential for leaks.

    Product
    TRANSPAC¿ IV BIFURCATED KIT WITH SAFESET" RESERVOIR AND BLOOD SAMPLING PORTS, 84" TUBING, 2 SQUEEZE FLUSHES, 2 DISPOSABLE TRANSDUCER, MACRODRIP (POLE MOUNT), Item No. 42500-06 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0446-2017·2016-11-23

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 820 Transpac IV Monitoring Kits with SafeSet Reservoirs due to a potential for leaks.

    Product
    TRANSPAC¿ IV MONITORING KIT WITH SAFESET" RESERVOIR AND BLOOD SAMPLING PORT, 60" TUBING, DISPOSABLE TRANSDUCER, 3 ML INTRAFLO¿ FLUSH, MACRODRIP (POLE MOUNT), Item No. 42641-06 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0430-2017·2016-11-23

    Farm Country Cheese House Recalls White Cheddar Due to Pasteurization Issues

    Farm Country Cheese House is voluntarily recalling White Cheddar cheese blocks because of inadequate pasteurization. The affected product was distributed in Michigan.

    Product
    White Cheddar, thirty-nine, 40 lb. blocks from Vat A and 25 40 lb. blocks from Vat C
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0500-2017·2016-11-23

    ICU Medical Recalls Cath Lab Kits Due to Potential Leak

    ICU Medical is recalling 272 cath lab kits containing SafeSet Reservoirs and Transpac IV transducers due to a potential for leak.

    Product
    CATH LAB KIT WITH 03ML FLUSH DEVICE FOR MEMORIAL HEALTHCARE, Item No. 46090-07 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0513-2017·2016-11-23

    ICU Medical Recalls Transpac IV Transducer Kits Due to Leak Risk

    ICU Medical is recalling specific SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    QUAD KIT WITH THREE TRANSPAC¿ AND 03ML FLUSH DEVICES FOR ST. FRANCIS HOSP., Item No. 46094-47 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0454-2017·2016-11-23

    ICU Medical Recalls Transpac IV Transducers Due to Potential Leak

    ICU Medical is recalling 1,480 Transpac IV transducers with SafeSet Reservoirs due to a potential leak. The products were distributed nationwide.

    Product
    TRANSPAC¿ IV DISPOSABLE TRANSDUCER WITH STOPCOCKS AND WITHOUT COVERS, Item No. 42664-01NS The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0567-2017·2016-11-23

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 25 units of Transpac IV Monitoring Kits due to a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    Transpac¿ IV Monitoring Kit w/84" Red Stripe TBG and 03 ml Squeeze Flush Device, Item No. 46113-91 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0542-2017·2016-11-23

    ICU Medical Recalls Transpac IV Transducer Kits Due to Leak Risk

    ICU Medical is recalling 120 units of TP4 Monitoring Kits with SafeSet Reservoirs due to a potential leak. The devices are distributed nationwide.

    Product
    TP4 Monitoring Kit w/84" Safeset" Reservoir, 03 ml Squeeze Flush and Needleless Valve, Item No. 46101-53 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0460-2017·2016-11-23

    ICU Medical Recalls Transpac IV Transducers Due to Potential Leak

    ICU Medical is recalling 100 units of Transpac IV transducers and SafeSet Reservoir kits due to a potential for leak.

    Product
    CATH LAB KIT #2 FOR MARY HITCHCOCK MEM. HOSP., Item No. 46057-18 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0445-2017·2016-11-23

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 280 units of Transpac IV Monitoring Kits with SafeSet Reservoirs due to a potential for leak.

    Product
    TRANSPAC¿ IV MONITORING KIT WITH SAFESET" RESERVOIR AND BLOOD SAMPLING PORT, 60" TUBING, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42640-06 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0462-2017·2016-11-23

    ICU Medical Recalls Transpac Pressure Transducer Kits Due to Leak Risk

    ICU Medical is recalling 60 units of Transpac pressure transducer kits due to a potential leak in the SafeSet Reservoir system.

    Product
    KIT FOR UNIVERSITY OF MICH. MOTT CATH LAB, Item No. 46061-49 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0550-2017·2016-11-23

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 260 units of Transpac IV Monitoring Kits because of a potential leak in the SafeSet Reservoir and blood sampling kits.

    Product
    Transpac¿ IV Monitoring Kit, 84", Disposable Transducer, 3 ml Squeeze Flush, Macrodrip, Red Stripe Pressure Tubing and Color Plug, Item No. 46104-31 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0510-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak

    ICU Medical is recalling 210 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    BIFURCATED KIT W/03ML FLUSH DEVICE FOR DUKE UNIVERSITY, Item No. 46094-20 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0519-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir Kits Due to Leak Risk

    ICU Medical is recalling 120 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    CATH LAB KIT, Item No. 46096-25 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0568-2017·2016-11-23

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 260 Transpac IV Monitoring Kits with SafeSet Reservoirs due to a potential for leaks.

    Product
    Transpac¿ IV Monitoring Kit w/ Safeset" Reservoir and Blood Sampling Port, 03 ml Squeeze Flush Device, Macrodrip (Patient Mount), Item No. 46114-24 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0589-2017·2016-11-23

    Siemens Recalls Advia Chemistry Calibrator Due to Bilirubin Bias

    Siemens is recalling Advia Chemistry Calibrators because incorrect values may cause a 41% positive bias in Direct Bilirubin patient results.

    Product
    Advia Chemistry Calibrator For in vitro diagnostic use in the calibration of ADVIA¿ Chemistry systems for the following methods: Albumin (ALB, ALB_c), Direct Bilirubin (DBIL_2), Total Bilirubin (TBIL_2), Calcium (CA, CA_c, CA_2, CA_2c), Cholesterol (CHOL), Creatinine (CREA…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0549-2017·2016-11-23

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling specific Transpac IV monitoring kits because the SafeSet Reservoir and blood sampling components may leak.

    Product
    TRANSPAC¿ IV MONITORING KIT, 60", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP AND RED PLUGS, Item No. 46104-10 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0485-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak

    ICU Medical is recalling 950 SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    Double LINE SAFESET" KIT WITH 03ML FLUSH DEVICE FOR E.U.S.H.C., Item No. 46076-26 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0424-2017·2016-11-23

    ICU Medical Recalls Transpac IV Transducers Due to Potential Leak

    ICU Medical is recalling specific Transpac IV transducers and SafeSet Reservoir kits due to a potential for leak.

    Product
    TRANSPAC¿ IV DISPOSABLE TRANSDUCER WITH 4 FT. CABLE EXTENSION AND STOPCOCK, Item No. 42582-08 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0475-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir Kits Due to Leak Risk

    ICU Medical is recalling 200 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    ARTERIAL SET-UP W/03ML FLUSH DEVICE FOR ORLANDO REG. MED. CTR., Item No. 46068-49 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0520-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak

    ICU Medical is recalling 1,320 SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    CATH LAB KIT w/3 PORT ''ON'' MANIFOLD, WASTE BAG, TP4, SYRINGES & 30 ml BURETTE, Item No. 46096-26 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0552-2017·2016-11-23

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 20 units of Transpac IV Monitoring Kits due to a potential leak in the SafeSet Reservoir and blood sampling kits.

    Product
    Transpac¿ IV Monitoring Kit, 60", Disposable Transducer, 30 ML Intraflo¿ Flush, Pall Air Filter, Macrodrip (Pole Mount), Item No. 46104-63 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0400-2017·2016-11-23

    Bayer Medrad Intego PET Infusion Pump Recall for Pressure Testing Failure

    Bayer Healthcare is recalling PET Infusion Pumps used with the Medrad Intego system because they may fail pressure testing specifications when more than one year past the manufacturing date.

    Product
    PET Infusion Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0464-2017·2016-11-23

    ICU Medical Recalls Transpac Transducer Kits Due to Potential Leak

    ICU Medical is recalling 100 units of Transpac transducer kits due to a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    TRANSDUCER KIT W/30ML FLUSH DEVICE FOR CHILDRENS HOSP. OF WISC., Item No. 46063-11 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0490-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir Kits Due to Leak Risk

    ICU Medical is recalling 90 SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    MONITORING KIT W/03ML FLUSH DEVICE FOR MEDICAL COLLEGE OF GA, Item No. 46080-51 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0527-2017·2016-11-23

    ICU Medical Recalls Transpac IV Transducer Kits Due to Leak Risk

    ICU Medical is recalling 430 units of Transpac IV transducer kits due to a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    SINGLE (1) DISPOSABLE TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR LUTHERAN GEN. HOSP., Item No. 46097-66 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0499-2017·2016-11-23

    ICU Medical Recalls Cath Lab Kits Due to Potential Leak

    ICU Medical is recalling 360 units of Cath Lab Kits for Genesis Health Care due to a potential leak in the SafeSet Reservoir and blood sampling kits.

    Product
    CATH LAB KIT FOR GENESIS HEALTH CARE, Item No. 46089-74 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0474-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak

    ICU Medical is recalling 290 SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    OPEN HEART MONITORING KIT WITH 03ML FLUSH DEVICE FOR ORLANDO REG. MED. CTR., Item No. 46068-48 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0476-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir Kits Due to Leak Potential

    ICU Medical is recalling 40 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    NEONATAL KIT WITH 30ML FLUSH DEVICE FOR YALE-NEW HAVEN HOSP., Item No. 46068-65 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0548-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir Kits Due to Leak Potential

    ICU Medical is recalling 220 SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    Monitoring Kit w/TP4, 30 ml Squeeze Flush and Needleless Valve, Item No. 46104-07 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0525-2017·2016-11-23

    ICU Medical Recalls Transpac Transducer Kits Due to Leak Risk

    ICU Medical is recalling 60 units of Transpac IV transducer kits due to a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    TRANSDUCER KIT FOR MEDICAL CTR. AT BOWLING GREEN, Item No. 46097-64 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0555-2017·2016-11-23

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 440 units of Transpac IV Monitoring Kits due to a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    Transpac¿ IV Monitoring Kit w/03 ml Squeeze Flush and Macrodrip, Item No. 46106-91 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0497-2017·2016-11-23

    ICU Medical Recalls Transpac Pressure Transducers Due to Leak Risk

    ICU Medical is recalling 30 units of Transpac pressure transducers and SafeSet reservoirs due to a potential leak.

    Product
    TRIPLE MK W/03ML FLUSH DEVICE FOR UNIV OF PENN. HEALTH SYSTEMS, Item No. 46088-08 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0417-2017·2016-11-23

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 140 units of Transpac IV Monitoring Kits due to a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    TRANSPAC¿ IV MONITORING KIT, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP, Item No. 011-46106-45 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0486-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak

    ICU Medical is recalling 30 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    HEART KIT W/03ML FLUSH DEVICE FOR ST. JOSEPHS HOSP., Item No. 46076-59 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0488-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak

    ICU Medical is recalling 110 SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    CATH LAB KIT FOR BAPTIST M. C., Item No. 46078-52 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0396-2017·2016-11-23

    Roche Recalls Hemoglobin A1c Test Cassettes Due to High Results

    Roche Diagnostics is recalling specific Hemoglobin A1c test cassettes because they may produce erroneously high results.

    Product
    COBAS INTEGRA 800 Tina-Quant Hemoglobin A1cDX Gen.2 Hemoglobin A1cDX test Catalog number 04528123160
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0480-2017·2016-11-23

    ICU Medical Recalls Transpac Pressure Kits Due to Leak Risk

    ICU Medical is recalling 10 units of Transpac pressure kits due to a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    TRIPLE PRESSURE KIT WITH 03ML FLUSH DEVICE FOR METHODIST M.C. OF ILLINOIS, Item No. 46072-51 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0585-2017·2016-11-23

    C.R. Bard Recalls C-Max Cutting Loop Electrodes Due to Defect

    C.R. Bard is recalling 70 units of C-Max Cutting Loop Electrodes because the contact part could separate, affecting device functionality.

    Product
    C-Max" Cutting Loop Electrodes, Storz One-Stem, 24 Fr, .014in., .35 mm, Sterile, Rx only, Manufactured by: C.R. Bard, Inc., Covington, GA 30014.
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0434-2017·2016-11-23

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling specific Transpac IV monitoring kits because of a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    TRANSPAC¿ IV TRIFURCATED MONITORING KIT 60 INCH, 3 DISPOSABLE TRANSDUCERS, 3 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42590-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0477-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak

    ICU Medical is recalling 20 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    KIT W/30ML FLUSH DEVICE FOR ALL CHILDRENS Hospital, Item No. 46070-30 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0460-2017·2016-11-23

    Nobel Bakery Recalls Apricot Perouk and Assorted Cookies for Undeclared Wheat

    Nobel Bakery is recalling Apricot Perouk and Assorted cookies because they may contain undeclared wheat, posing a risk to individuals with wheat allergies or celiac disease.

    Product
    Orange Cake, Net Wt. 10 oz. (283g), UPC 7 80890 28604 2.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0537-2017·2016-11-23

    ICU Medical Recalls Cardiac Kits with Potential Leak Risk

    ICU Medical is recalling 370 cardiac kits with 0.3 ml flush devices due to a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    CARDIAC KIT WITH 03 ml FLUSH DEVICE, Item No. 46099-57 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0574-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak

    ICU Medical is recalling 30 SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    CATH LAB KIT W/3 PORT "ON" MANIFOLD, WASTE BAG, SYRINGE & TP4, Item No. AG7891-NS The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0427-2017·2016-11-23

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling Transpac IV Monitoring Kits because the SafeSet Reservoir and blood sampling components may leak.

    Product
    Transpac¿ IV Monitoring Kit, 60", Disposable Transducer, 3 ml Squeeze Flush Device, Macrodrip, Item No. 42584-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0437-2017·2016-11-23

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 40 units of Transpac IV Monitoring Kits due to a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    Transpac¿ IV Monitoring Kit w/4 Way Stopcock, 3 Way Stopcock and 24" Arterial Pressure Tubing, Item No. 42594-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0414-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir Kits Due to Leak Risk

    ICU Medical is recalling 20 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    4 Port "ON" Manifold (600 psi) w/4 ft. Transpac¿ IV, Item No. 46300-14NS The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·16V849000·2016-11-23

    Chrysler Recalls 2017 Jeep Wranglers for Fuel Tank Valve Defect

    Chrysler is recalling 2017 Jeep Wranglers built in November 2016 because a cracked fuel tank valve may cause leaks or over-fueling, increasing fire risk.

    Product
    JEEP — JEEP WRANGLER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0575-2017·2016-11-23

    ICU Medical Recalls Left Heart Kits Due to Potential Leak

    ICU Medical is recalling 80 units of Left Heart Kits due to a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    LEFT HEART KIT, Item No. AG8052-NS The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0450-2017·2016-11-23

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 60 units of Transpac IV Monitoring Kits due to a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    TRANSPAC¿ IV BIFURCATED MONITORING KIT 72 INCH, 2 DISPOSABLE TRANSDUCER, 2 3 ML INTRAFLO¿ FLUSHES, MACRODRIP (POLE MOUNT), Item No. 42651-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0481-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak

    ICU Medical is recalling 560 SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    CARDIAC CATHETERIZATION WASTE MANAGEMENT SYSTEM LEFT HEART KIT, Item No. 46073-14 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0504-2017·2016-11-23

    ICU Medical Recalls Arterial Pressure Kits Due to Leak Risk

    ICU Medical is recalling 380 arterial pressure kits containing Transpac transducers due to a potential leak risk.

    Product
    ARTERIAL PRESSURE KIT W/03ML FLUSH DEVICE FOR LEBONHEUR CHILDRENS HOSP., Item No. 46091-31 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0516-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak

    ICU Medical is recalling 40 SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    Cath Lab Kit w/3 Port "ON" Manifold, 03 ml Flush Device, Waste Bag, HPT, Syringe, TP4 and 30 ml Contrast Reservoir, Item No. 46095-16 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0458-2017·2016-11-23

    ICU Medical Recalls Transpac IV Transducer Kits Due to Leak Risk

    ICU Medical is recalling 1,240 SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    ART LINE KIT W/ 3ML FLUSH DEVICE FOR JACKSON MEM. HOSP., Item No. 46053-14 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0544-2017·2016-11-23

    ICU Medical Recalls Transpac Pressure Transducers Due to Leak Risk

    ICU Medical is recalling 140 units of Transpac pressure transducers and SafeSet Reservoir kits due to a potential for leaks.

    Product
    Transpac¿ w/Safeset Reservoir, Squeeze 03 ml Flush and Needleless Valve, Item No. 46101-82 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0561-2017·2016-11-23

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling specific Transpac IV Monitoring Kits because of a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    Transpac¿ IV Monitoring Kit, 60", 03 ml Squeeze Flush Device, 2 3 Way Stopcocks and Macrodrip, Item No. 46112-10 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0474-2017·2016-11-23

    Baptista Bakery Bread Recalled for Undeclared Wheat Flour Allergen

    Batista Bakery & Pastries is recalling Portuguese Sliced Bread because the label failed to declare wheat flour as required by FALCPA.

    Product
    Baptista Bakery & Pastry Inc. Portugese Sliced Bread, 16 oz. plastic
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0572-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak

    ICU Medical is recalling 20 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    4 Port "ON" Manifold (600 psi) w/4 ft. Transpac¿ IV, Item No. 46300-14NS The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0538-2017·2016-11-23

    ICU Medical Recalls Transpac IV Transducer Kits Due to Leak Risk

    ICU Medical is recalling specific Transpac IV transducer kits because of a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    Transpac¿ 4 kit w/72" Macrodrip¿ Admin Set, Item No. 46099-77 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0431-2017·2016-11-23

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Potential

    ICU Medical is recalling 4,360 Transpac IV Monitoring Kits due to a potential leak in the SafeSet Reservoir and blood sampling kits.

    Product
    TRANSPAC¿ IV MONITORING KIT, 60", DISPOSABLE TRANSDUCER, 3 ML INTRAFLO¿ FLUSH, MACRODRIP (POLE MOUNT), Item No. 42587-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0466-2017·2016-11-23

    ICU Medical Recalls Transpac Pressure Transducers Due to Leak Risk

    ICU Medical is recalling 140 units of Transpac Disposable Straight Pressure Transducers and SafeSet Reservoir kits due to a potential for leak.

    Product
    CATH LAB KIT #3 FOR MARY HITCHCOCK HOSP., Item No. 46063-37 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0455-2017·2016-11-23

    ICU Medical Recalls Transpac Pressure Transducer Kits Due to Leak Risk

    ICU Medical is recalling 500 units of Monitoring Kit #3 with SafeSet Reservoirs due to a potential leak. The kits are distributed nationwide.

    Product
    Monitoring Kit #3 w/03 ml Flush Device for Childrens Hosp, Item No. 46010-34 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0563-2017·2016-11-23

    ICU Medical Recalls Transpac IV Transducers Due to Potential Leak

    ICU Medical is recalling 180 units of Transpac IV Disposable Transducers due to a potential leak in the SafeSet Reservoir and blood sampling kits.

    Product
    Transpac¿ IV Disposable Transducer w/Stopcocks w/o Cap and Covers, Item No. 46112-30NS The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0541-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak

    ICU Medical is recalling 40 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    Right Heart Cath Lab Kit w/2 Port "OFF" Manifold (600 psi), 72" Spike Set, Transpac¿ IV and 48" HP Tubing, Item No. 46100-87 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0492-2017·2016-11-23

    ICU Medical Recalls Transpac IV Transducer Kits Due to Leak Risk

    ICU Medical is recalling specific SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    MONITORING KIT WITH 03ML FLUSH DEVICE FOR LEHIGH VALLEY HOSPITAL CENTER, Item No. 46085-47 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0483-2017·2016-11-23

    ICU Medical Recalls Transpac Transducer Kits Due to Potential Leak

    ICU Medical is recalling 150 units of Transpac transducer kits with SafeSet Reservoirs due to a potential for leak.

    Product
    TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR ALL CHILDRENS HOSP., Item No. 46076-21 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0526-2017·2016-11-23

    ICU Medical Recalls Transpac IV Transducer Kits Due to Leak Risk

    ICU Medical is recalling specific Transpac IV transducer kits because of a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    TRIPLE (3) DISPOSABLE TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR LUTHERAN GEN. HOSP., Item No. 46097-65 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0587-2017·2016-11-23

    Inpeco Laboratory Automation Systems Recalled for Burnt Sockets

    Inpeco is recalling FlexLab, Accelerator a3600, and Aptio Automation systems because field reports indicate burnt Schuko sockets and smoke.

    Product
    FlexLab, Accelerator a3600 and Aptio Automation are modular systems designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0554-2017·2016-11-23

    ICU Medical Recalls Transpac IV Transducer Kits Due to Leak Risk

    ICU Medical is recalling 60 units of Transpac IV transducer kits due to a potential leak. The kits were distributed nationwide.

    Product
    Monitoring Kit w/TP4, 03 ml Squeeze Flush, Blue Stripe Pressure Tubing, 3 Way Stopcocks, Blue Plugs and Needleless Valve, Item No. 46106-49 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0472-2017·2016-11-23

    Baptista Bakery Italian Bread Recalled for Undeclared Wheat Flour

    Batista Bakery & Pastries, Inc. is recalling 30 units of 16 oz. Italian Bread because the label fails to declare wheat flour as required by FALCPA.

    Product
    Baptista Bakery & Pastry Inc. Italian Bread, 16 oz. plastic
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0560-2017·2016-11-23

    ICU Medical Recalls Transpac IV Trifurcated Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 100 units of Transpac IV Trifurcated Monitoring Kits due to a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    Transpac¿ IV Trifurcated Monitoring Kit w/03 ml Squeeze Flush Device, Arterial Safeset" Reservoir and Needleless Valves, Item No. 46112-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and…
    Category
    Medical Device
    Distribution
    Distributed nationwide

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