The Recall Desk

FDA (Devices) recall action 62127

Genzyme Corporation recalled 2 products on 2012-06-27

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
2012-06-27
Critical
0
Units
5,165

Why these products were recalled

Sterility of product may be compromised due to packaging defect

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)··2012-06-27

    Genzyme Recalls Seprafilm Adhesion Barrier Packs Due to Packaging Defect

    Genzyme is recalling Seprafilm Procedure Packs because a packaging defect may compromise the product's sterility. The recall affects units distributed in the US and South Korea.

    Product
    seprafilm¿ Procedure Pack ADHESION BARRIER Re-order Number: 5086-02 Product Usage: Seprafilm Adhesion Barrier is indicated for use in patients undergoing abdominal or pelvic laparotomy as an adjunct intended to reduce the incidence, extent and severity of postoperative adh
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2012-06-27

    Genzyme Recalls Seprafilm Adhesion Barrier Due to Packaging Sterility Risk

    Genzyme Corporation is recalling 1,285 units of Seprafilm Single Site Adhesion Barrier because a packaging defect may compromise product sterility.

    Product
    seprafilm¿ Single Site ADHESION BARRIER Re-order Number: 6641-01 Product Usage: Seprafilm Adhesion Barrier is indicated for use in patients undergoing abdominal or pelvic laparotomy as an adjunct intended to reduce the incidence, extent and severity of postoperative adhesion
    Category
    Distribution
    0 states