🔍 RecallPedia

General Pack, part number AMS2967(A General Pack, part number AMS3239(A General Pack, part number AMS3709(B General Pack, part number AMS5341 General Pack, part number AMS5694

Class I - Dangerous
🏥 Medical Devices Recalled: January 11, 2017 Windstone Medical Packaging Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot number and expiration date 100415, 9/23/2019 100737, 9/30/2019 100981, 10/20/2019 101069, 9/6/2019 101739, 10/19/2019 101816, 10/14/2019 83797, 5/12/2018 84203, 5/26/2018 84668, 5/17/2018 84793, 2/3/2019 85141, 6/8/2018 85421, 7/28/2018 85504, 8/30/2018 86008, 7/8/2018 86260, 9/9/2018 86481, 9/5/2018 86586, 9/27/2018 86774, 8/8/2018 86837, 9/12/2018 87291, 9/30/2018 87456, 9/30/2018 87754, 1/7/2019 88321, 9/6/2018 88648, 12/29/2018 88657, 12/2/2018 88764, 10/8/2018 89333, 12/25/2018 89429, 12/29/2018 94713, 12/14/2018 94739, 1/25/2019 94783, 12/16/2018 95286, 11/12/2018 95349, 1/10/2019 95432, 1/24/2019 95459, 1/21/2019 95928, 1/23/2019 95999, 3/9/2019 96009, 1/7/2019 96501, 1/6/2019 96934, 5/30/2019 97201, 5/5/2019 97338, 5/13/2019 97459, 6/4/2019 97854, 6/14/2019 98176, 6/29/2019 98263, 6/11/2019 98677, 6/3/2019 99291, 6/12/2019 99385, 6/11/2019 99682, 6/29/2019 99712, 6/5/2019 99889, 9/4/2019 99926, 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:

General Pack, part number AMS2967(A General Pack, part number AMS3239(A General Pack, part number AMS3709(B General Pack, part number AMS5341 General Pack, part number AMS5694

Product Codes/Lot Numbers:

Lot number and expiration date 100415, 9/23/2019 100737, 9/30/2019 100981, 10/20/2019 101069, 9/6/2019 101739, 10/19/2019 101816, 10/14/2019 83797, 5/12/2018 84203, 5/26/2018 84668, 5/17/2018 84793, 2/3/2019 85141, 6/8/2018 85421, 7/28/2018 85504, 8/30/2018 86008, 7/8/2018 86260, 9/9/2018 86481, 9/5/2018 86586, 9/27/2018 86774, 8/8/2018 86837, 9/12/2018 87291, 9/30/2018 87456, 9/30/2018 87754, 1/7/2019 88321, 9/6/2018 88648, 12/29/2018 88657, 12/2/2018 88764, 10/8/2018 89333, 12/25/2018 89429, 12/29/2018 94713, 12/14/2018 94739, 1/25/2019 94783, 12/16/2018 95286, 11/12/2018 95349, 1/10/2019 95432, 1/24/2019 95459, 1/21/2019 95928, 1/23/2019 95999, 3/9/2019 96009, 1/7/2019 96501, 1/6/2019 96934, 5/30/2019 97201, 5/5/2019 97338, 5/13/2019 97459, 6/4/2019 97854, 6/14/2019 98176, 6/29/2019 98263, 6/11/2019 98677, 6/3/2019 99291, 6/12/2019 99385, 6/11/2019 99682, 6/29/2019 99712, 6/5/2019 99889, 9/4/2019 99926, 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-1305-2017

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