The Recall Desk

FDA (Devices) recall action 64527

Arrow International Inc recalled 2 products on 2013-04-17

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
2013-04-17
Critical
0
Units
825

Why these products were recalled

Potential to have an internal leak at the fill port of the stainless steel tip, which may necessitate removal and replacement of the catheter.

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

  • HighFDA (Devices)··2013-04-17

    Arrow International Recalls FiberOptix Intra-Aortic Balloon Catheter Kits

    Arrow International is recalling 637 units of FiberOptix Intra-Aortic Balloon Catheter Kits due to a potential internal leak at the fill port.

    Product
    Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 40 cc; Product Number: IAB-05840-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation therapy.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2013-04-17

    Arrow International Recalls FiberOptix Intra-Aortic Balloon Catheter Kits

    Arrow International is recalling 188 units of FiberOptix Intra-Aortic Balloon Catheter Kits due to a potential internal leak at the fill port.

    Product
    Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 30 cc; Product Number: IAB-05830-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation therapy.
    Category
    Distribution
    0 states