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.

1–25 of 162

HighFDA (Devices)··2016-11-23
ICU Medical Recalls Pediatric CVL Monitoring Kits Due to Leak Risk
ICU Medical is recalling 40 Pediatric CVL Monitoring Kits containing Transpac IV transducers due to a potential for leak.
Product
PEDIATRIC CVL MONITORING KIT W/03ML FLUSH DEVICE FOR YALE NEW HAVEN HOSP., Item No. 46094-06 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in…
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HighFDA (Devices)··2016-11-23
ICU Medical Recalls SafeSet Reservoir and Blood Sampling Kits
ICU Medical is recalling specific SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.
Product
CATH LAB KIT w/3 PORT "OFF" MANIFOLD, WASTE BAG, GUIDE WIRE, SPLASH STOP, NEEDLE & TP-4, Item No. 46098The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting…
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HighFDA (Devices)··2016-11-23
ICU Medical Recalls Transpac IV Transducer Kits Due to Leak Risk
ICU Medical is recalling 160 units of Transpac IV transducer kits due to a potential leak. The affected products were distributed nationwide.
Product
TRIPLE KIT W/SAFESET" AND 03ML FLUSH DEVICE FOR O.H.S.U., Item No. 46080-38 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…
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HighFDA (Devices)··2016-11-23
ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk
ICU Medical is recalling Transpac IV bifurcated monitoring kits because of a potential for leak in the SafeSet Reservoir and blood sampling components.
Product
TRANSPAC¿ IV BIFURCATED MONITORING KIT, 72" 2 DISPOSABLE TRANSDUCERS, with 2 STOPCOCKS, 2 3 ml SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42500-19 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a…
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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", DISPOSABLE TRANSDUCER, 3 ML INTRAFLO¿ FLUSH, MICRODRIP¿ (POLE MOUNT), Item No. 42608-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor…
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HighFDA (Devices)··2016-11-23
ICU Medical Recalls SafeSet Reservoir Kits Due to Leak Risk
ICU Medical is recalling 25 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.
Product
Neonate Kit With 30 ml Flush Device For Driscoll Foundation For Children, Item No. 46094-71 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 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, MICRODRIP¿ (POLE MOUNT), Item No. 42607-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by…
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HighFDA (Devices)··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
CATH LAB KIT w/4 PORT "ON" MANIFOLD, WASTE BAG, SYRINGE, WASTE BASIN, SHARPSTOP & TP4, Item No. 46098-76 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting…
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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 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…
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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 60 units of Transpac IV Trifurcated Monitoring Kits due to a potential for leak in the SafeSet Reservoir and blood sampling components.
Product
Transpac¿ IV Trifurcated Monitoring Kit w/84" Safeset" Reservoir, 03 ml Squeeze Flush Device, Needleless Valves, Red, Blue and Yellow Stripe TBG, Item No. 46113-88 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that…
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HighFDA (Devices)··2016-11-23
ICU Medical Recalls Transpac IV Transducers Due to Potential Leak
ICU Medical is recalling 200 units of Transpac IV transducers and SafeSet Reservoir kits due to a potential for leak.
Product
TRIFURCATED MK W/03ML FLUSH DEVICE FOR UNIV. HEALTH SYSTEM, Item No. 46097-62 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…
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HighFDA (Devices)··2016-11-23
ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk
ICU Medical is recalling 10 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 84" w/03 ml Squeeze Flush Device, Red, Blue and Yellow Stripe Tubing, Item No. 46113-90 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure…
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HighFDA (Devices)··2016-11-23
ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak
ICU Medical is recalling 190 SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.
Product
ART/CVP KIT W/03ML FLUSH DEVICE FOR MILWAUKEE CHILDRENS HOSP., Item No. 46059-28 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…
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HighFDA (Devices)··2016-11-23
ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak
ICU Medical is recalling 80 SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.
Product
PERFUSION PUMP KIT FOR MEMORIAL HOSP., Item No. 46070-79 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…
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HighFDA (Devices)··2016-11-23
ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk
ICU Medical is recalling 240 Transpac IV Monitoring Kits because of a potential leak in the SafeSet Reservoir and blood sampling components.
Product
Transpac¿ IV Monitoring Kit w/ Safeset Reservoir, 24" Tubing,03 ml Intraflo¿ Flush and Needleless Valve, Item No. 46103-68 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor…
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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 NEONATAL, 12", 3 STOPCOCKS, DISPOSABLE TRANSDUCER, 30 ML SQUEEZE FLUSH (FOR USE WITH INFUSION PUMP), Item No. 42634-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a…
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HighFDA (Devices)··2016-11-23
ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak
ICU Medical is recalling 90 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.
Product
Cath Lab Kit w/Waste Bag System, 3 Port "OFF" Manifold (600 psi), Transpac¿ IV, 72" Spike Sets and 48" HP Tubing, Item No. 46100-83 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 specific SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leaks.
Product
CVP ARTERIAL LINE KIT WITH 03ML FLUSH DEVICE FOR KANSAS HEART HOSP, Item No. 46091-04 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…
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HighFDA (Devices)··2016-11-23
ICU Medical Recalls Transpac IV Transducer Kits Due to Leak Risk
ICU Medical is recalling 10 units of Transpac IV transducer kits due to a potential leak in the SafeSet Reservoir.
Product
Trifurcated Monitoring Kit w/84" Safeset" Reservoir, TP4, 03 ml Squeeze Flush and Needleless Valve, Item No. 46101-55 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by…
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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…
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HighFDA (Devices)··2016-11-23
ICU Medical Recalls Transpac IV Kits Due to Potential Leak
ICU Medical is recalling 325 units of Transpac IV Kits due to a potential leak in the SafeSet Reservoir and blood sampling kits.
Product
Transpac¿ IV Kit w/2 3-Way Stopcocks and 48" Pressure TBG, Item No. 46112-77 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…
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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…
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HighFDA (Devices)··2016-11-23
ICU Medical Recalls SafeSet Reservoir Kits Due to Leak Potential
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 FOR SALINA REGIONAL, Item No. 46092-34 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 can be…
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HighFDA (Devices)··2016-11-23
ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk
ICU Medical is recalling 130 units of Transpac IV Bifurcated Monitoring Kits due to a potential leak in the SafeSet Reservoir and blood sampling kits.
Product
Transpac¿ IV Bifurcated Monitoring Kit 48", 2 Disposable Transducers, 2 03 ml Intraflo¿ Flush Devices, Macrodrip (Pole Mount), Item No. 011-42592-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a…
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HighFDA (Devices)··2016-11-23
ICU Medical Recalls Cardiac Catheterization Kits Due to Leak Risk
ICU Medical is recalling 70 cardiac catheterization kits containing Transpac IV transducers due to a potential leak in the SafeSet Reservoir system.
Product
Cardiac Catheterization Right Heart Kit w/2-Station, Right Hand, On, High Pressure Manifold and Transpac¿ IV Disposable Transducer, Item No. 46083-03 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a…
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