Hernia Pack, Kit number AMS1519 convenience custom kits used for general surgery in hospital operating room
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Numbers/ Expiration Dates: 62455 8/19/2013 61070 9/10/2013 58150 1/30/2014 59474 1/31/2014 63203 9/11/2014 64165 9/14/2014 65059 9/27/2014 67591 9/29/2014 68544 5/7/2015 68386 5/24/2015 68720 9/14/2015 70550 10/8/2015 69342 10/17/2015 74095 12/2/2015 73780 12/23/2015 76033 2/22/2016 76082 2/22/2016 72977 2/25/2016 76032 2/27/2016 56835 5/29/2016
- 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.
โ ๏ธ 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:
Hernia Pack, Kit number AMS1519 convenience custom kits used for general surgery in hospital operating room
Product Codes/Lot Numbers:
Lot Numbers/ Expiration Dates: 62455 8/19/2013 61070 9/10/2013 58150 1/30/2014 59474 1/31/2014 63203 9/11/2014 64165 9/14/2014 65059 9/27/2014 67591 9/29/2014 68544 5/7/2015 68386 5/24/2015 68720 9/14/2015 70550 10/8/2015 69342 10/17/2015 74095 12/2/2015 73780 12/23/2015 76033 2/22/2016 76082 2/22/2016 72977 2/25/2016 76032 2/27/2016 56835 5/29/2016
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0208-2017
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