Laparoscopic Pack, Kit number AMS2499 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: 62086 11/7/2015 65280 11/8/2015 62087 11/17/2015 65736 11/30/2015 64547 1/6/2016 67957 7/7/2016 67016 7/16/2016 67697 8/9/2016 69435 9/18/2016 70253 9/23/2016 70497 10/18/2016 70156 10/31/2016 70808 12/13/2016 71959 1/14/2017 73320 3/5/2017 72888 3/24/2017 73333 5/7/2017 75288 5/11/2017 76049 7/20/2017 78640 8/12/2017 78151 8/18/2017 76946 8/31/2017 77686 10/8/2017 77310 10/24/2017 69018 12/10/2017 78978 1/20/2018
- 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:
Laparoscopic Pack, Kit number AMS2499 convenience custom kits used for general surgery in hospital operating room
Product Codes/Lot Numbers:
Lot numbers/Expiration dates: 62086 11/7/2015 65280 11/8/2015 62087 11/17/2015 65736 11/30/2015 64547 1/6/2016 67957 7/7/2016 67016 7/16/2016 67697 8/9/2016 69435 9/18/2016 70253 9/23/2016 70497 10/18/2016 70156 10/31/2016 70808 12/13/2016 71959 1/14/2017 73320 3/5/2017 72888 3/24/2017 73333 5/7/2017 75288 5/11/2017 76049 7/20/2017 78640 8/12/2017 78151 8/18/2017 76946 8/31/2017 77686 10/8/2017 77310 10/24/2017 69018 12/10/2017 78978 1/20/2018
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0219-2017
Related Recalls
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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).