The Recall Desk

FDA (Devices) recall action 67983

Edwards Lifesciences, LLC recalled 2 products on 2014-04-23

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
2014-04-23
Critical
0
Units
42,000

Why these products were recalled

Potential for separation of dilator tips.

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)··2014-04-23

    Edwards Lifesciences Recalls Fem-Flex II Arterial Cannulae Due to Tip Separation

    Edwards Lifesciences is recalling 28,885 Fem-Flex II Arterial and Femoral Cannulae because the dilator tips may separate.

    Product
    Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae with Duraflo Coating, arterial cannula sizes 16, 18 and 20 French, Models DFEMII016AS, DFEMII018AS, DFEMII020AS, DIIFEMII016A, DIIFEMII018A, and DIIFEMII020A.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2014-04-23

    Edwards Lifesciences Recalls Fem-Flex II Arterial Cannulae Due to Tip Separation

    Edwards Lifesciences is recalling 13,115 Fem-Flex II Arterial and femoral Cannulae because the dilator tips may separate. The recall covers units distributed nationwide and to foreign, government, and military consignees.

    Product
    Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae, arterial cannula sizes 16, 18 and 20 French, models: FEMII016A, FEMII016AS, FEMII018A, FEMII018AS, FEMII020A, and FEMII020AS.
    Category
    Distribution
    0 states