Surgical Pack, Kit number PSS3540 and PSS3540(A convenience custom kits used for general surgery in hospital operating room

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot Number/ Expiration Date: 75513 6/25/2016 79705 1/26/2018 79982 2/14/2018
  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:
Windstone Medical Packaging, Inc.
Reason for Recall:
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Surgical Pack, Kit number PSS3540 and PSS3540(A convenience custom kits used for general surgery in hospital operating room

Product Codes/Lot Numbers:

Lot Number/ Expiration Date: 75513 6/25/2016 79705 1/26/2018 79982 2/14/2018

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0273-2017

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