The Recall Desk

FDA (Devices) recall action 64696

Baxter Healthcare Corp. recalled 4 products on 2013-05-15

The FDA (Devices) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2013-05-15
Critical
0
Units
—

Why these products were recalled

Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.

The agency’s own wording, quoted from the enforcement report.

1–4 of 4

  • HighFDA (Devices)··2013-05-15

    Baxter Recalls Non-DEHP Catheter Extension Sets Due to Sterile Barrier Compromise

    Baxter Healthcare is recalling specific lots of Non-DEHP Catheter Extension Set Kits because separating packages can compromise the sterile barrier of adjacent units.

    Product
    A) Product Code 2N8220: Non-DEHP Catheter Extension Set Kit, Single use only, includes: 1) 7.7", Vol. 1.10 mL, Luer Activated Valve for IV Access, Male Luer Lock Adapter, 2) Medium Catheter Stabilization Device, and 3) Foam Tape Strips; B) Product Code 2N8221: Non-DEHP…
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    Distribution
    0 states
  • HighFDA (Devices)··2013-05-15

    Baxter Recalls Non-DEHP Y-Type Catheter Extension Sets Due to Sterility Compromise

    Baxter Healthcare is recalling 228,200 units of Non-DEHP Y-Type Catheter Extension Sets because separating packages can compromise the sterile barrier of adjacent units.

    Product
    A) Product Code 2N3371: Non-DEHP Y-Type Catheter Extension Set, 5.7", Vol. 0.8 mL, 2 Injection Sites, Male Luer Lock Adapter, Single use only Product Usage: This device is indicated for use in blood sampling and the administration of solutions. The InterLink Injection…
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    0 states
  • ModerateFDA (Devices)··2013-05-15

    Baxter Recalls Non-DEHP Y-Type Catheter Extension Set Kits

    Baxter Healthcare is recalling 513,000 units of IV extension tubing kits because separating packages can compromise the sterile barrier.

    Product
    A) Product Code 2N8371: Non-DEHP Y-Type Catheter Extension Set Kit, 6.0", Vol. 1.0 mL, 2 Luer Activated Valves, Male Luer Lock Adapter, Single use only Product Usage: The IV extension tubing kits are intended to provide users with a ready to use set up for the…
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    Distribution
    0 states
  • HighFDA (Devices)··2013-05-15

    Baxter Recalls Non-DEHP Catheter Extension Sets Due to Sterile Barrier Compromise

    Baxter Healthcare is recalling specific lots of Non-DEHP catheter extension sets because separating packages can compromise the sterile barrier of adjacent units.

    Product
    A) Product Code 2N1191: Non-DEHP Y-Type Catheter Extension Set, 4.8", Vol. 0.6 mL, Male Luer Lock Adapter, Single use only; B) Product Code 2N1206: Non-DEHP I.V. Catheter Extension Set, 5.7", Vol. 0.7 mL, Male Luer Lock Adapter with Retractable Collar, Single use only…
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    Distribution
    0 states