🔍 RecallPedia

LapSac Introducer Set, Bag, Extraction, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to aid in the introduction of a LapSac during endoscopic surgical procedures.

Class I - Dangerous
🏥 Medical Devices Recalled: May 1, 2017 Cook Surgical Instruments Nationwide

What Should You Do?

  1. Check if you have this product:
    CATALOG NUMBER and GPN: 054300 & G15771 Dates of Manufacture: January 2012 to August 2015
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Cook Inc.
Reason for Recall:
COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

LapSac Introducer Set, Bag, Extraction, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to aid in the introduction of a LapSac during endoscopic surgical procedures.

Product Codes/Lot Numbers:

CATALOG NUMBER and GPN: 054300 & G15771 Dates of Manufacture: January 2012 to August 2015

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2315-2017

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