C-Section Pack, Kit number 002643-10, 002643-9, and AMS4449 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: 58207 8/31/2013 61591 1/2/2014 59228 1/19/2014 66522 1/31/2014 61763 3/5/2014 62929 9/10/2014 67485 9/19/2014 67664 9/21/2014 63835 9/22/2014 65290 9/30/2014 56956 6/18/2016 57666 6/23/2016 71060 10/13/2016 68943 10/26/2016 79065 11/9/2017 79842 1/25/2018 80908 2/15/2018
- 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:
C-Section Pack, Kit number 002643-10, 002643-9, and AMS4449 convenience custom kits used for general surgery in hospital operating room
Product Codes/Lot Numbers:
Lot Numbers/ Expiration Dates: 58207 8/31/2013 61591 1/2/2014 59228 1/19/2014 66522 1/31/2014 61763 3/5/2014 62929 9/10/2014 67485 9/19/2014 67664 9/21/2014 63835 9/22/2014 65290 9/30/2014 56956 6/18/2016 57666 6/23/2016 71060 10/13/2016 68943 10/26/2016 79065 11/9/2017 79842 1/25/2018 80908 2/15/2018
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0159-2017
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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).