Knee Arthroscopy Pack AMS2610, AMS2610(A, AMS3236, PSS2188(A, and PSS2208(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 Numbers/Expiration Dates: 63879 1/23/2014 58286 3/18/2014 58810 6/21/2014 62512 10/18/2014 63024 12/13/2014 65774 2/25/2015 68072 4/17/2015 68548 4/25/2015 70982 11/26/2015 73402 3/14/2016 74837 3/22/2016 75198 4/20/2016 67703 7/1/2016 78551 7/30/2016 78600 7/30/2016 68823 9/11/2016 68713 9/20/2016 71080 12/26/2016 72020 1/10/2017 73647 1/28/2017 73205 3/9/2017 73034 3/23/2017 77621 7/21/2017 79992 8/1/2017 77815 8/11/2017 80859 8/31/2017 77783 10/10/2017 75744 10/21/2017 79326 1/13/2018
  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:

Knee Arthroscopy Pack AMS2610, AMS2610(A, AMS3236, PSS2188(A, and PSS2208(A convenience custom kits used for general surgery in hospital operating room

Product Codes/Lot Numbers:

Lot Numbers/Expiration Dates: 63879 1/23/2014 58286 3/18/2014 58810 6/21/2014 62512 10/18/2014 63024 12/13/2014 65774 2/25/2015 68072 4/17/2015 68548 4/25/2015 70982 11/26/2015 73402 3/14/2016 74837 3/22/2016 75198 4/20/2016 67703 7/1/2016 78551 7/30/2016 78600 7/30/2016 68823 9/11/2016 68713 9/20/2016 71080 12/26/2016 72020 1/10/2017 73647 1/28/2017 73205 3/9/2017 73034 3/23/2017 77621 7/21/2017 79992 8/1/2017 77815 8/11/2017 80859 8/31/2017 77783 10/10/2017 75744 10/21/2017 79326 1/13/2018

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0211-2017

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