The Recall Desk

FDA (Devices) recall action 83593

Arrow International Inc recalled 2 products on 2019-10-02

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2019-10-02
Critical
0
Units
751

Why these products were recalled

Products may contain the incorrect banner card within the kit

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.

1–2 of 2

  • ModerateFDA (Devices)··2019-10-02

    Arrow Central Venous Catheterization Kit Recalled for Incorrect Banner Card

    Arrow International Inc is recalling 231 units of 8.5 Fr. X 16 cm Quad-Lumen Central Venous Catheterization Kits because they may contain the incorrect banner card.

    Product
    Arrow 8.5 Fr. X 16 cm Quad-Lumen Central Venous Catheterization Kit Product Code:AK-42854-P1A - Product Usage: The Arrow Central Venous Catheters are intended to permit venous access to the central circulation by way of the femoral, jugular or subclavian veins.
    Category
    Distribution
    0 states
  • LowFDA (Devices)··2019-10-02

    Arrow International Recalls Central Venous Access Kits Due to Incorrect Banner Card

    Arrow International Inc is recalling 520 units of ARROW+gard Blue PSI Kit Cath-Gard central venous access devices because they may contain the incorrect banner card.

    Product
    8.5 Fr. X 10 cm ARROW+gard Blue PSI Kit Cath-Gard for use with 7.5 - 8 Fr.Catheters Product Code: CDC-29803-1A - Product Usage: The MACTM Two-Lumen Central Venous Access Device with ARROWg+ard Blue¿ permits venous access and catheter introduction to the central circulation. It…
    Category
    Distribution
    0 states