Basin Pack, kit number AMS2497 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: 67015 7/5/2016 67549 8/10/2016 68418 7/7/2016 68820 9/19/2016 68959 9/12/2016 69548 9/20/2016 69852 10/23/2016 70495 10/20/2016 71780 12/11/2016 71957 10/20/2016 71958 1/7/2017 72481 3/15/2017 73643 1/22/2017 73644 4/10/2017 73850 4/23/2017 74062 7/9/2017 76185 7/11/2017 76345 8/31/2017 76673 10/21/2017 77769 10/4/2017 78025 9/22/2017 78741 1/17/2018 80940 8/8/2017
- 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:
Basin Pack, kit number AMS2497 convenience custom kits used for general surgery in hospital operating room
Product Codes/Lot Numbers:
Lot Numbers/Expiration Dates: 67015 7/5/2016 67549 8/10/2016 68418 7/7/2016 68820 9/19/2016 68959 9/12/2016 69548 9/20/2016 69852 10/23/2016 70495 10/20/2016 71780 12/11/2016 71957 10/20/2016 71958 1/7/2017 72481 3/15/2017 73643 1/22/2017 73644 4/10/2017 73850 4/23/2017 74062 7/9/2017 76185 7/11/2017 76345 8/31/2017 76673 10/21/2017 77769 10/4/2017 78025 9/22/2017 78741 1/17/2018 80940 8/8/2017
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0150-2017
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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).