The Recall Desk

FDA (Devices) recall action 74489

Arrow International Inc recalled 2 products on 2016-07-20

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
2016-07-20
Critical
0
Units
100

Why these products were recalled

Labeling error. Some shipping cartons labeled as ASK-04018-VUH contained ASK-04020-VUH kits; and some shipping cartons labeled as ASK-04020-VUH contained ASK-04018-VUH kits.

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

1–2 of 2

  • ModerateFDA (Devices)··2016-07-20

    Arrow Femoral Arterial Line Catheterization Kit Recalled for Labeling Error

    Arrow International Inc. is recalling 50 units of Femoral Arterial Line Catheterization Kits due to shipping carton labeling errors.

    Product
    Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D025180 Material ASK-04018-VUH Product Usage: The Arrow arterial catheterization device permits access to the peripheral arterial circulation.
    Category
    Distribution
    2 states
  • ModerateFDA (Devices)··2016-07-20

    Arrow Recalls Femoral Arterial Catheterization Kits Due to Labeling Error

    Arrow International Inc is recalling 50 femoral arterial catheterization kits because some shipping cartons contained the wrong product model.

    Product
    Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D025180 Material ASK-04018-VUH Product Usage: The Arrow arterial catheterization device permits access to the peripheral arterial circulation.
    Category
    Distribution
    2 states