The Recall Desk

FDA (Devices) recall action 63322

Ethicon, Inc. recalled 2 products on 2012-11-28

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
2012-11-28
Critical
0
Units
73,476

Why these products were recalled

SURGIFLO Hemostatic Matrix Kit & SURGIFLO Hemostatic Matrix Kit with Thrombin have an issue within the packing process where a cut could potentially breach the double Tyvek pouch of the packaging.

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

  • LowFDA (Devices)··2012-11-28

    Ethicon Surgiflo Hemostatic Matrix Kit Packaging Defect Recall

    Ethicon is recalling Surgiflo Hemostatic Matrix Kits due to a packaging defect that could breach the Tyvek pouch.

    Product
    ETHICON SURGIFLO HEMOSTATIC MATRIX KIT Plus FlexTip with Thrombin distributed by ETHICON ETHICON Inc. Somerville, NJ 08876 USA Ref 2993 SURGIFLO Hemostatic Matrix, mixed with sterile saline or thrombin solution, is indicated for surgical procedures (except ophthalmic)
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2012-11-28

    Ethicon Recalls Surgiflo Hemostatic Matrix Kits Due to Packaging Defect

    Ethicon is recalling Surgiflo Hemostatic Matrix kits because a potential cut in the packaging could breach the sterile Tyvek pouch.

    Product
    ETHICON SURGIFLO HEMOSTATIC MATRIX Distributed by ETHICON ETHICON, Inc. Somerville, NJ 08876, USA SURGIFLO Hemostatic Matrix is a topical absorbable hemostat consisting of a flowable gelatin matrix (paste). This kit also contains components necessary for preparing and applyi
    Category
    Distribution
    0 states