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.

126–150 of 162

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 electr
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HighFDA (Devices)··2016-11-23
ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk
ICU Medical is recalling 1,960 Transpac IV Monitoring Kits with SafeSet Reservoirs due to a potential for leaks. The products were distributed nationwide.
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. 42642-06 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 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 by
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HighFDA (Devices)··2016-11-23
ICU Medical Recalls Transpac IV Transducer Kits Due to Leak Risk
ICU Medical is recalling 235 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.
Product
MONITORING KIT W/30 ML FLUSH DEVICE FOR EGLESTON HOSP., Item No. 46094-50 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 electrical
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HighFDA (Devices)··2016-11-23
ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Potential
ICU Medical is recalling 500 units of Transpac IV Monitoring Kits due to a potential leak in the SafeSet Reservoir and blood sampling components.
Product
TRANSPAC¿ IV MONITORING KIT, 9", DISPOSABLE TRANSDUCER, 3 ML INTRAFLO¿ FLUSH, MACRODRIP (PATIENT MOUNT), Item No. 42589-05 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 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 electri
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HighFDA (Devices)··2016-11-23
ICU Medical Recalls SafeSet Reservoir and Blood Sampling Kits
ICU Medical is recalling certain SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.
Product
PERFUSION KIT FOR UNIV. OF IOWA, Item No. 46091-51 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 electrical currents that can be i
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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
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 pressur
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HighFDA (Devices)··2016-11-23
ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk
ICU Medical is recalling 3,640 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 (INTENDED FOR PATIENT MOUNT), Item No. 42583-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure mo
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HighFDA (Devices)··2016-11-23
ICU Medical Recalls SafeSet Reservoir Kits Due to Leak Risk
ICU Medical is recalling 40 SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leaks.
Product
MONITORING KIT WITH 03ML FLUSH DEVICE FOR NYU MED CTR, Item No. 46094-37 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
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HighFDA (Devices)··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 can
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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 mon
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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 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 that
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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 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 int
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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 electri
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HighFDA (Devices)··2016-11-23
ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak
ICU Medical is recalling 640 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.
Product
SINGLE LINE SAFESET" KIT WITH 03ML FLUSH DEVICE FOR E.U.S.H.C., Item No. 46076-25 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 el
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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 co
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HighFDA (Devices)··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 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 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 cathe
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HighFDA (Devices)··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 change
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HighFDA (Devices)··2016-11-23
ICU Medical Recalls Transpac IV Transducers Due to Potential Leak
ICU Medical is recalling 120 units of Transpac IV transducers and SafeSet Reservoir kits due to a potential for leak.
Product
BIFURCATED TRANSPAC¿ 4 WITH 03ML FLUSH DEVICE FOR BUFFALO GENERAL HOSP., Item No. 46063-34 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressur
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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 and SafeSet Reservoirs due to a potential leak. The affected units were distributed nationwide.
Product
TRANSPAC¿ IV MONITORING KIT, NEONATAL, 24", WITH DISPOSABLE TRANSDUCER, 30 ML INTRAFLO¿ FLUSH (INFUSION PUMP), Item No. 42588-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure mo
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HighFDA (Devices)··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 el
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HighFDA (Devices)··2016-11-23
ICU Medical Recalls Transpac IV Transducers Due to Potential Leak
ICU Medical is recalling 710 units of Transpac IV transducers with SafeSet Reservoirs due to a potential leak.
Product
TRANSPAC¿ IV DISPOSABLE TRANSDUCER WITH 4 FT. CABLE EXTENSION AND STOPCOCK WITHOUT COVERS, Item No. 42663-01NS The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by convertin
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