The Recall Desk

FDA (Devices) recall action 74966

ICU Medical, Inc. recalled 24 products on 2016-09-21

The FDA (Devices) publishes a recall like this one as 24 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 24 pages.

Products
24
Announced
2016-09-21
Critical
0
Units
9,205

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.

1–24 of 24

  • HighFDA (Devices)··2016-09-21

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling specific 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 SafeSet Blood Sampling Ports, 60" TUBING, Disposable Transducer, 3 ML Intraflo Flush, Macrodrip (Pole Mount), Item No. 42619-08 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that…
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    0 states
  • HighFDA (Devices)··2016-09-21

    ICU Medical Recalls SafeSet Reservoir Kits Due to Leak Risk

    ICU Medical is recalling 20 units of Bifurcated SafeSet Kits with 03mL Flush Devices due to a potential for leaks.

    Product
    Bifurcated SafeSet Kit with 03mL Flush Device, Item No. 46091-75 Product Usage: 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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    0 states
  • HighFDA (Devices)··2016-09-21

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 420 Transpac IV Monitoring Kits with SafeSet Reservoirs due to a potential leak. The affected units were distributed nationwide in the US.

    Product
    Transpac IV Monitoring Kit with SafeSet 84inch Arterial Pressure Tubing, Reservoir, Squeeze Flush and 2 Needleless Valves, Item No. 011-42646-66 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces…
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  • HighFDA (Devices)··2016-09-21

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 90 units of Transpac IV Trifurcated Monitoring Kits due to a potential for leaks in the SafeSet Reservoir and blood sampling components.

    Product
    Transpac IV Trifurcated Monitoring Kit with 84" SafeSet Reservoir, 03 ml Squeeze Flush and Needleless Valves, Item No. 42650-66 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a…
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    0 states
  • HighFDA (Devices)··2016-09-21

    ICU Medical Recalls Transpac IV Trifurcated Kits Due to Leak Risk

    ICU Medical is recalling 250 units of Transpac IV Trifurcated Kits due to a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    Transpac IV Trifurcated Kit With Safeset Reservoir And 2 Blood Sampling Ports, 84 inch Tubing, 3 3 ml Intraflo Flushes, 3 Disposable Transducers, Macrodrip, Item No. 42500-04 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure…
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    0 states
  • HighFDA (Devices)··2016-09-21

    ICU Medical Recalls Transpac IV Transducer Kits Due to Leak Risk

    ICU Medical is recalling 140 units of TP4 Kits with SafeSet Reservoirs due to a potential for leaks. The affected medical devices were distributed nationwide.

    Product
    TP4 Kit with 10cc SafeSet Reservoir, Needleless Valve, Filter Millex and Admin Set, Item No. 46104-65 Usage: 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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    0 states
  • HighFDA (Devices)··2016-09-21

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

    ICU Medical is recalling 150 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 with SafeSet Reservoir, Port and 03 ml Squeeze Flush Devices, Item No. 46110-84 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and…
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    0 states
  • HighFDA (Devices)··2016-09-21

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 100 units of Transpac IV Monitoring Kits with SafeSet Reservoirs due to a potential leak hazard.

    Product
    Transpac IV Monitoring Kit with SafeSet 84" Arterial Pressure Tubing, Reservoir, Squeeze Flush and Needleless Valve, Item No. 46104-53 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a…
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    0 states
  • HighFDA (Devices)··2016-09-21

    ICU Medical Recalls Pediatric Pressure Transducer Kits Due to Leak Risk

    ICU Medical is recalling 20 Pediatric Kits with 30mL Flush Devices due to a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    Pediatric Kit with 30mL Flush Device, Item No. 46099-10 Product Usage: 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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    0 states
  • HighFDA (Devices)··2016-09-21

    ICU Medical Recalls SafeSet Reservoir Kits Due to Leak Potential

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

    Product
    Monitoring Kit with TP4, 30 ml Squeeze Flush Device, 10 cc Contamination Syringe and Needleless Valve, Item No. 46112-65 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter…
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    0 states
  • HighFDA (Devices)··2016-09-21

    ICU Medical Recalls Transpac IV Bifurcated Kits Due to Leak Risk

    ICU Medical is recalling 10 units of Transpac IV Bifurcated Kits with SafeSet Reservoirs due to a potential for leaks.

    Product
    Transpac IV Bifurcated Kit with SafeSet Reservoir, 03 ml Squeeze Flush and Needleless Valve, Item No. 42500-66 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure…
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    0 states
  • HighFDA (Devices)··2016-09-21

    ICU Medical Recalls SafeSet Reservoir Kits Due to Leak Potential

    ICU Medical is recalling 20 units of Single Monitoring Kits with 30mL Flush Devices due to a potential for leak in the SafeSet Reservoir and blood sampling components.

    Product
    Single Monitoring Kit with 30mL Flush Device, Item No. 46073-38 Product Usage: 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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    0 states
  • HighFDA (Devices)··2016-09-21

    ICU Medical Recalls SafeSet Reservoir and Blood Sampling Kits

    ICU Medical is recalling 70 units of SafeSet Reservoir and blood sampling kits due to a potential leak.

    Product
    Monitoring Kit with 03mL Flush Device, Item No. 46080-57 Product Usage: 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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    0 states
  • HighFDA (Devices)··2016-09-21

    ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak

    ICU Medical is recalling 150 units of SafeSet Reservoir kits with Transpac IV transducers due to a potential for leak.

    Product
    Triple Line SafeSet Kit with 03mL Flush Device, Item No. 46076-27 Product Usage: 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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    0 states
  • HighFDA (Devices)··2016-09-21

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 1,420 Transpac IV Monitoring Kits because of a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    Transpac IV Monitoring Kit with 2 SafeSet 84" Arterial Pressure Tubing, Reservoir, 03 mL Squeeze Flush and 2 Needleless Valves, Item No. 42646-66 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces…
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    0 states
  • HighFDA (Devices)··2016-09-21

    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 SafeSet Reservoir and Blood Sampling Port, 24" Tubing, Disposable Transducer, 03 mL Squeeze Flush, Macrodrip (Patient Mount), Item No. 42648-06 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular…
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    0 states
  • HighFDA (Devices)··2016-09-21

    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 with 03 ml Squeeze Flush, SafeSet Reservoir, 2 Needleless Valves, Mounts and Bracket, Item Nos. 46107-35, 46110-07 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between…
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    0 states
  • HighFDA (Devices)··2016-09-21

    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 with 2 SafeSet Reservoir and 2 Blood Sampling Ports, 84" Tubing, Disposable Transducer, 3 mL Squeeze Flush, Macrodrip (Pole Mount), Item No. 42646-06 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure…
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    0 states
  • HighFDA (Devices)··2016-09-21

    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
    5 Port OFF Manifold with Transpac IV, Item No. 46100-29 Usage: 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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    0 states
  • HighFDA (Devices)··2016-09-21

    ICU Medical Recalls Transpac IV Transducer Kits Due to Leak Risk

    ICU Medical is recalling 110 units of Double Kit with SafeSet and 03mL Flush Device due to a potential for leak.

    Product
    Double Kit with SafeSet and 03mL Flush Device, Item No. 46080-37 Product Usage: 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
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    0 states
  • HighFDA (Devices)··2016-09-21

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

    ICU Medical is recalling 760 Transpac IV Trifurcated Monitoring Kits because of a potential for leaks in the SafeSet Reservoir and blood sampling components.

    Product
    Transpac IV Trifurcated Monitoring Kit with SafeSet Reservoir and 2 Blood Sampling Ports, 84", 3.3mL Squeeze Flushes, 3 Disposable Transducers, Macrodrip (Pole Mount), Item No. 42650-06 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an…
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    0 states
  • HighFDA (Devices)··2016-09-21

    ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak

    ICU Medical is recalling 125 SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    SafeSet Kit with 30 mL Flush Device, Item No. 46083-42 Product Usage: 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
    Distribution
    0 states
  • HighFDA (Devices)··2016-09-21

    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
    Monitoring Kit with 30mL Flush Device, Item No. 46076-15 Product Usage: 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
    Distribution
    0 states
  • HighFDA (Devices)··2016-09-21

    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
    Monitoring Kit with TP4, 30 ml Squeeze Flush and Needleless Valve, Item No. 46103-22 Usage: 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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    0 states