Shoulder Pack, part number AMS2936 Shoulder Pack, part number AMS3638 Shoulder Pack, part number AMS3711(B Shoulder Pack, part numbere AMS4212 Shoulder Pack, part number AMS6460 Shoulder Pack, part numberPSS1852(A

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot number and expiration date 100412, 8/14/2018 100837, 10/19/2019 101181, 10/9/2019 83278, 5/27/2018 83634, 5/20/2017 84945, 6/24/2017 85147, 7/28/2017 85150, 7/15/2018 85258, 6/10/2018 85541, 7/14/2018 85554, 7/2/2018 85555, 7/7/2018 86259, 7/2/2017 86308, 9/20/2018 86488, 10/29/2018 86512, 9/28/2018 86688, 11/16/2019 86747, 8/3/2018 87122, 10/7/2017 87798, 10/28/2017 88399, 10/19/2017 88404, 11/20/2018 89040, 12/14/2017 89088, 12/10/2018 89598, 11/18/2018 89887, 12/16/2018 95111, 12/12/2017 95287, 6/15/2019 95811, 2/23/2018 96607, 1/7/2018 97133, 2/7/2018 97290, 5/22/2019 98325, 3/26/2018 98687, 6/14/2019 99065, 6/13/2018 99548, 9/27/2019
  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 of the custom Aligned Medical Solutions (AMS) kits 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:

Shoulder Pack, part number AMS2936 Shoulder Pack, part number AMS3638 Shoulder Pack, part number AMS3711(B Shoulder Pack, part numbere AMS4212 Shoulder Pack, part number AMS6460 Shoulder Pack, part numberPSS1852(A

Product Codes/Lot Numbers:

Lot number and expiration date 100412, 8/14/2018 100837, 10/19/2019 101181, 10/9/2019 83278, 5/27/2018 83634, 5/20/2017 84945, 6/24/2017 85147, 7/28/2017 85150, 7/15/2018 85258, 6/10/2018 85541, 7/14/2018 85554, 7/2/2018 85555, 7/7/2018 86259, 7/2/2017 86308, 9/20/2018 86488, 10/29/2018 86512, 9/28/2018 86688, 11/16/2019 86747, 8/3/2018 87122, 10/7/2017 87798, 10/28/2017 88399, 10/19/2017 88404, 11/20/2018 89040, 12/14/2017 89088, 12/10/2018 89598, 11/18/2018 89887, 12/16/2018 95111, 12/12/2017 95287, 6/15/2019 95811, 2/23/2018 96607, 1/7/2018 97133, 2/7/2018 97290, 5/22/2019 98325, 3/26/2018 98687, 6/14/2019 99065, 6/13/2018 99548, 9/27/2019

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1369-2017

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