The Recall Desk

FDA (Devices) recall action 71028

ICU Medical, Inc. recalled 8 products on 2015-05-13

The FDA (Devices) publishes a recall like this one as 8 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 8 pages.

Products
8
Announced
2015-05-13
Critical
0
Units
23,100

Why these products were recalled

ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage.

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.

States named across these recalls

1–8 of 8

  • HighFDA (Devices)··2015-05-13

    ICU Medical Recalls MicroClave T-Connectors Due to Potential Leakage

    ICU Medical is recalling 5,100 units of MicroClave T-Connectors because potential connection separation issues could lead to leakage.

    Product
    127" (323cm) Transfer Set w/Check Valve, MicroClave T-Connector, Anti-Siphon Valve, Clamp, Luer Lock, Non-DEHP Tubing, Item No. B33351 Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
    Category
    Distribution
    9 states
  • HighFDA (Devices)··2015-05-13

    ICU Medical Recalls 98-inch Transfer Sets Due to Connection Separation

    ICU Medical is recalling 50 units of 98-inch Transfer Sets because potential connection separation could lead to leakage.

    Product
    98" (249 cm) Transfer Set w/MicroClave T-Connector, 2 Check Valves, Luer Lock, Non-DEHP Tubing, Item No. B3372 Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
    Category
    Distribution
    9 states
  • HighFDA (Devices)··2015-05-13

    ICU Medical Recalls MicroClave T-Connectors Due to Potential Leakage

    ICU Medical is recalling MicroClave T-Connectors because potential connection separation issues could lead to leakage.

    Product
    107" (272 cm) Ext Set w/2 Check Valves, MicroClave T-Connector, Clamp, Rotating Luer, Non-DEHP Tubing, Item No. B33041 Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
    Category
    Distribution
    9 states
  • HighFDA (Devices)··2015-05-13

    ICU Medical Recalls MicroClave T-Connectors Due to Connection Separation Risk

    ICU Medical is recalling specific MicroClave T-Connectors because they may separate, causing fluid leakage. The recall affects 250 units distributed in nine US states.

    Product
    119" (302 cm) Transfer Set w/MicroClave T-Connector, Smallbore Quadfuse Ext Set w/3 MicroClave (Red, Glow Rings), 5 Check Valves, 0.2 Micron Filter, Rotating Luer, Non-DEHP Tubing, Item No. B33037 Product Usage: IV Administration sets are intended for the infusion and…
    Category
    Distribution
    9 states
  • HighFDA (Devices)··2015-05-13

    ICU Medical Recalls MicroClave T-Connectors Due to Connection Separation Risk

    ICU Medical is recalling MicroClave T-Connectors because potential connection separation issues could lead to leakage.

    Product
    98" (249 cm) Transfer Set w/MicroClave T-Connector, Check Valve, Anti-Siphon Valve, Trifuse Ext Set w/2 MicroClave, Rotating Luer, Non-DEHP Tubing, Item No. B3338 Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are…
    Category
    Distribution
    9 states
  • HighFDA (Devices)··2015-05-13

    ICU Medical Recalls MicroClave T-Connectors Due to Connection Separation Risk

    ICU Medical is recalling specific MicroClave T-Connectors because they may separate, causing fluid leakage.

    Product
    113" (287cm) Transfer Set w/MicroClave T-Connector, Check Valve, Anti-Siphon Valve, Smallbore Quadfuse Ext Set w/MicroClave, 4 Clamps (Blue, 2 Red, White), Rotating Luer, Non-DEHP Tubing, Item No. B33303 Product Usage: IV Administration sets are intended for the infusion and…
    Category
    Distribution
    9 states
  • HighFDA (Devices)··2015-05-13

    ICU Medical Recalls MicroClave T-Connectors Due to Connection Separation

    ICU Medical is recalling 1,500 MicroClave T-Connectors because potential connection separation issues could lead to leakage.

    Product
    104" (264 cm) Transfer Set w/MicroClave T-Connector, Check Valve, Smallbore Trifuse Ext w/2 MicroClave, Anti-Siphon Valve, 3 Clamps (White, Red, Blue), Rotating Luer, Non-DHEP Tubing, Item No. B33065 Product Usage: IV Administration sets are intended for the infusion and…
    Category
    Distribution
    9 states
  • HighFDA (Devices)··2015-05-13

    ICU Medical Recalls MicroClave T-Connectors Due to Connection Separation Risk

    ICU Medical is recalling 13,800 MicroClave T-Connectors because potential connection separation issues could lead to leakage.

    Product
    108" (274 cm) Transfer Set w/Check Valve, MicroClave T-Connector, Anti-Siphon Valve, Clamp, Luer Lock, Non-DEHP Tubing, Item No. B33326
    Category
    Distribution
    9 states