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 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 can
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HighFDA (Devices)··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
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HighFDA (Devices)··2016-11-23
ICU Medical Recalls SafeSet Reservoir Kits Due to Leak Risk
ICU Medical is recalling 180 SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.
Product
CATH LAB KIT WITH 03ML FLUSH DEVICE FOR CARLE CLINIC, Item No. 46087-37 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 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 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 cathet
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HighFDA (Devices)··2016-11-23
ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk
ICU Medical is recalling 20 units of Transpac IV Bifurcated Monitoring Kits due to a potential leak in the SafeSet Reservoir and blood sampling components.
Product
Transpac¿ IV Bifurcated Monitoring Kit w/03 ml Squeeze Flush Device, PT Tubings, 3-Way Stopcocks and Admin Set, Item No. 46114-80 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure m
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HighFDA (Devices)··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 elec
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HighFDA (Devices)··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 e
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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 WITH DISPOSABLE TRANSDUCER, 3 ML INTRAFLO¿ FLUSH AND MACRODRIP (POLE MOUNT), Item No. 42606-05 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 Transpac IV Monitoring Kits Due to Leak Risk
ICU Medical is recalling 520 Transpac IV Monitoring Kits because of a potential leak in the SafeSet Reservoir and blood sampling components.
Product
Transpac¿ IV Monitoring Kit w/Arterial 84" Safeset" Reservoir, 03 ml Squeeze Flush Device and Needleless Valves, Item No. 46112-13 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 and Blood Sampling Kits
ICU Medical is recalling 20 units of SafeSet Reservoir and blood sampling kits due to a potential leak hazard.
Product
OPEN HEART KIT W/03ML FLUSH DEVICE FOR CUMBERLAND COUNTY HOSP., Item No. 46094-08 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 el
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HighFDA (Devices)··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 pressur
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HighFDA (Devices)··2016-11-23
ICU Medical Recalls Pediatric Arterial Kits Due to Potential Leak
ICU Medical is recalling 650 Pediatric Arterial Kits with SafeSet Reservoirs and Transpac IV transducers due to a potential for leak.
Product
PEDIATRIC ARTERIAL KIT W/30ML FLUSH DEVICE FOR STANFORD UNIV. HOSP., Item No. 46065-65 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 in
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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 in the SafeSet Reservoir system.
Product
QUAD TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR LUBBOCK HEART HOSP., Item No. 46097-36 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 int
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HighFDA (Devices)··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 in
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HighFDA (Devices)··2016-11-23
ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak
ICU Medical is recalling 100 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.
Product
CARDIAC CATH LAB KIT FOR PRESBYTERIAN INTERCOMMUNITY HOSP., Item No. 46095-33 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 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 curr
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HighFDA (Devices)··2016-11-23
ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak
ICU Medical is recalling 200 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. 42598-01 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 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
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HighFDA (Devices)··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 elect
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HighFDA (Devices)··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
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HighFDA (Devices)··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 elec
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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
Expression MR IBP DPT Kit, I/N, Box 20, Item No. 989803194641 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 th
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HighFDA (Devices)··2016-11-23
ICU Medical Recalls Transpac Transducer Kits Due to Leak Risk
ICU Medical is recalling specific Transpac IV transducer kits because of a potential leak. The recall covers 1,440 units distributed nationwide.
Product
TRIFURCATED DISPOSABLE TRANSDUCER KIT W/03ML FLUSH DEVICE FOR JOHNS HOPKINS/BAYVIEW, Item No. 46088-74 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting change
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HighFDA (Devices)··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 el
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HighFDA (Devices)··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 e
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