🔍 RecallPedia

Total Joint Pack, Kit number 006358-5 and 006358-6 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 Number/ Expiration Date: 58057 5/6/2014 58493 5/30/2014 61598 7/28/2014 59008 8/21/2014 60647 8/31/2014 62544 1/16/2015 63813 2/28/2015 66309 4/13/2015 67352 11/1/2015 73747 3/1/2016 77176 6/17/2016 56393 7/3/2016 79087 8/31/2016
  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:

Total Joint Pack, Kit number 006358-5 and 006358-6 convenience custom kits used for general surgery in hospital operating room

Product Codes/Lot Numbers:

Lot Number/ Expiration Date: 58057 5/6/2014 58493 5/30/2014 61598 7/28/2014 59008 8/21/2014 60647 8/31/2014 62544 1/16/2015 63813 2/28/2015 66309 4/13/2015 67352 11/1/2015 73747 3/1/2016 77176 6/17/2016 56393 7/3/2016 79087 8/31/2016

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0276-2017

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