Head and Neck Pack, kit numbers AMS1373(A, AMS1869, AMS2534, and AMS2534(A. 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: 62890 3/28/2014 61286 5/28/2014 61286 5/28/2014 59473 4/20/2015 59560 7/3/2015 60355 7/17/2015 60356 7/22/2015 60357 7/23/2015 60452 8/29/2015 61629 9/3/2015 60755 10/3/2015 61443 10/19/2015 65058 11/1/2015 64558 11/6/2015 65918 11/13/2015 66516 11/15/2015 65281 11/16/2015 61558 11/17/2015 62751 11/21/2015 64660 11/21/2015 62752 11/25/2015 61971 11/29/2015 64624 11/30/2015 72235 12/3/2015 67959 12/12/2015 69436 12/16/2015 68587 12/21/2015 69183 12/21/2015 71969 12/21/2015 65701 12/23/2015 67341 12/26/2015 70809 12/26/2015 62944 1/8/2016 72839 5/8/2016 57471 6/5/2016 57615 6/26/2016 68222 7/5/2016 58757 8/9/2016 67888 8/10/2016 59028 8/15/2016 68864 9/19/2016 69701 10/6/2016 69063 10/10/2016 69678 10/23/2016 69679 10/26/2016
- 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.
⚠️ 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:
Head and Neck Pack, kit numbers AMS1373(A, AMS1869, AMS2534, and AMS2534(A. convenience custom kits used for general surgery in hospital operating room
Product Codes/Lot Numbers:
Lot Numbers/ Expiration Dates: 62890 3/28/2014 61286 5/28/2014 61286 5/28/2014 59473 4/20/2015 59560 7/3/2015 60355 7/17/2015 60356 7/22/2015 60357 7/23/2015 60452 8/29/2015 61629 9/3/2015 60755 10/3/2015 61443 10/19/2015 65058 11/1/2015 64558 11/6/2015 65918 11/13/2015 66516 11/15/2015 65281 11/16/2015 61558 11/17/2015 62751 11/21/2015 64660 11/21/2015 62752 11/25/2015 61971 11/29/2015 64624 11/30/2015 72235 12/3/2015 67959 12/12/2015 69436 12/16/2015 68587 12/21/2015 69183 12/21/2015 71969 12/21/2015 65701 12/23/2015 67341 12/26/2015 70809 12/26/2015 62944 1/8/2016 72839 5/8/2016 57471 6/5/2016 57615 6/26/2016 68222 7/5/2016 58757 8/9/2016 67888 8/10/2016 59028 8/15/2016 68864 9/19/2016 69701 10/6/2016 69063 10/10/2016 69678 10/23/2016 69679 10/26/2016
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0206-2017
Related Recalls
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Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994
Windstone Medical Packaging
The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections and the ability to prime (occlusion).
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A
Windstone Medical Packaging
The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections and the ability to prime (occlusion).