FDA (Devices) recall action 75491

ICU Medical, Inc. recalled 162 products on 2016-11-23

The FDA (Devices) publishes a recall like this one as 162 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 162 pages.

Products: 162
Announced: 2016-11-23
Critical: 0
Units: 210,737

Why these products were recalled

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

51–75 of 162

HighFDA (Devices)··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 leaks.
Product
MONITORING KIT WITH 03ML FLUSH DEVICE FOR CHRIST HOSPITAL, Item No. 46054-42 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 electri
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HighFDA (Devices)··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 c
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HighFDA (Devices)··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 convert
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HighFDA (Devices)··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 currents
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HighFDA (Devices)··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 in
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HighFDA (Devices)··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
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HighFDA (Devices)··2016-11-23
ICU Medical Recalls SafeSet Reservoir and Blood Sampling Kits
ICU Medical is recalling 40 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.
Product
Cath Lab Left Heart Kit w/3 Port Manifold "OFF" (600 psi), Transpac¿ IV, Waste Bag System and 10 cc Control Syringe, Item No. 46300-11NS The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pre
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HighFDA (Devices)··2016-11-23
ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk
ICU Medical is recalling 2,200 Transpac IV Monitoring Kits because of a potential leak in the SafeSet Reservoir and blood sampling components.
Product
TRANSPAC¿ IV MONITORING KIT SAFESET" RESERVOIR AND 2 BLOOD SAMPLING PORTS, 60" TUBING, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42644-06 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that i
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HighFDA (Devices)··2016-11-23
ICU Medical Recalls SafeSet Reservoir Kits Due to Leak Risk
ICU Medical is recalling 100 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.
Product
2 PORT RIGHT "OFF" MANIFOLD w/ADMIN SET 72" PT, 3 WAY STOPCOCK, TP4 & 1 WAY STOPCOCK, Item No. 46098-79 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting chang
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HighFDA (Devices)··2016-11-23
ICU Medical Recalls Transpac IV Transducers Due to Potential Leak
ICU Medical is recalling specific Transpac IV transducers with SafeSet Reservoirs due to a potential for leak.
Product
TRANSPAC¿ IV DISPOSABLE TRANSDUCER WITH 4 FT. CABLE EXTENSION AND 1 WAY FM-FM STOPCOCK, Item No. 46104-35 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting cha
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HighFDA (Devices)··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 convert
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HighFDA (Devices)··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 pressur
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HighFDA (Devices)··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 electr
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HighFDA (Devices)··2016-11-23
ICU Medical Recalls Transpac IV Transducer Kits Due to Leak Risk
ICU Medical is recalling 130 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.
Product
TRIFURCATED KIT W/03ML FLUSH DEVICE FOR DUKE UNIVERSITY, Item No. 46094-21 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 electrica
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HighFDA (Devices)··2016-11-23
ICU Medical Recalls Transpac IV Transducers Due to Potential Leak
ICU Medical is recalling 380 units of Transpac IV Disposable Transducers with Stopcocks due to a potential for leak in the SafeSet Reservoir and blood sampling kits.
Product
TRANSPAC¿ IV DISPOSABLE TRANSDUCER WITH STOPCOCKS, Item No. 42500-03 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical curr
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HighFDA (Devices)··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 tha
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HighFDA (Devices)··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 pres
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HighFDA (Devices)··2016-11-23
ICU Medical Recalls Transpac IV Transducers Due to Potential Leak
ICU Medical is recalling 880 Transpac IV transducers and SafeSet Reservoir kits due to a potential for leak. The products were distributed nationwide.
Product
TRIFURCATED DISP. TRANSDUCER W/03ML FLUSH DEVICE FOR JOHNS HOPKINS HOSP, Item No. 46086-20 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressur
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HighFDA (Devices)··2016-11-23
ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak
ICU Medical is recalling 10 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.
Product
SAFESET" KIT W/03ML FLUSH DEVICE FOR HOLMES REG. M.C., Item No. 46097-30 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
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HighFDA (Devices)··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
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HighFDA (Devices)··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
OPEN HEART KIT WITH 03ML FLUSH DEVICE FOR FLETCHER ALLEN HEALTH CARE, Item No. 46063-77 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 i
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HighFDA (Devices)··2016-11-23
ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak
ICU Medical is recalling 140 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.
Product
Cath Lab Kit w/03 ml Squeeze Flush, Pressure Tubing, Guidewire, 10 cc Syringes and 3 Way Stopcock, Item No. 46098-87NS The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by c
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HighFDA (Devices)··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 el
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HighFDA (Devices)··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 p
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SevereFDA (Devices)··2016-11-23
ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak
ICU Medical is recalling 205 SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.
Product
Cath Lab Kit For Elkhart Hosp., Item No. 46078-17 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 in
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