🔍 RecallPedia

Pacemaker Kit, Kit number AMS4281 convenience custom kits used for general surgery in hospital operating room

Class I - Dangerous
🏥 Medical Devices Recalled: April 22, 2015 Windstone Medical Packaging Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot Numbers/ Expiration Dates: 77873 7/30/2016 78569 7/30/2016 78933 9/18/2017
  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:

Pacemaker Kit, Kit number AMS4281 convenience custom kits used for general surgery in hospital operating room

Product Codes/Lot Numbers:

Lot Numbers/ Expiration Dates: 77873 7/30/2016 78569 7/30/2016 78933 9/18/2017

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0256-2017

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