ENT Pack, part number AMS3237(A ENT Pack, part number AMS4214
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot number and expiration date 84530, 5/25/2018 84588, 5/12/2018 85139, 7/14/2018 85655, 8/1/2018 86310, 9/26/2018 86480, 9/3/2018 86749, 9/21/2018 87287, 8/11/2019 88184, 9/4/2018 88318, 11/19/2018 88647, 10/5/2018 89495, 9/30/2019 89589, 12/10/2018 95103, 1/2/2019 96194, 1/18/2019 96922, 5/11/2019 97787, 6/9/2019 98676, 6/27/2019
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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:
ENT Pack, part number AMS3237(A ENT Pack, part number AMS4214
Product Codes/Lot Numbers:
Lot number and expiration date 84530, 5/25/2018 84588, 5/12/2018 85139, 7/14/2018 85655, 8/1/2018 86310, 9/26/2018 86480, 9/3/2018 86749, 9/21/2018 87287, 8/11/2019 88184, 9/4/2018 88318, 11/19/2018 88647, 10/5/2018 89495, 9/30/2019 89589, 12/10/2018 95103, 1/2/2019 96194, 1/18/2019 96922, 5/11/2019 97787, 6/9/2019 98676, 6/27/2019
Distribution:
Nationwide distribution
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1294-2017
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