General Pack, Kit numbers: AMS2334, AMS2334(A, AMS2967, AMS2967(A, AMS3239, AMS3709, and AMS3709(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: 64285 3/3/2014 61278 3/4/2014 62888 3/28/2014 67339 11/27/2014 64287 10/26/2015 65277 11/1/2015 64286 11/4/2015 65531 11/15/2015 65566 11/20/2015 65215 11/26/2015 70153 12/5/2015 67953 12/7/2015 71459 12/12/2015 69644 12/14/2015 69127 12/16/2015 70377 12/19/2015 67952 12/24/2015 64642 12/26/2015 68630 12/26/2015 71458 12/27/2015 64656 1/5/2016 71965 5/7/2016 72838 5/8/2016 73354 5/12/2016 71966 5/15/2016 68316 9/18/2016 71083 10/28/2016 69577 11/16/2016 71499 12/27/2016 72690 1/14/2017 72222 1/25/2017 73248 3/5/2017 73815 4/30/2017 75445 5/13/2017 75892 7/8/2017 76336 7/17/2017 78746 8/6/2017 80739 8/7/2017 76447 8/7/2017 78102 8/15/2017 78417 9/30/2017 77353 10/1/2017 78847 11/9/2017 78648 1/9/2018 78946 1/25/2018 80448 2/28/2018
- 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:
General Pack, Kit numbers: AMS2334, AMS2334(A, AMS2967, AMS2967(A, AMS3239, AMS3709, and AMS3709(A. convenience custom kits used for general surgery in hospital operating room
Product Codes/Lot Numbers:
Lot Numbers/ Expiration Dates: 64285 3/3/2014 61278 3/4/2014 62888 3/28/2014 67339 11/27/2014 64287 10/26/2015 65277 11/1/2015 64286 11/4/2015 65531 11/15/2015 65566 11/20/2015 65215 11/26/2015 70153 12/5/2015 67953 12/7/2015 71459 12/12/2015 69644 12/14/2015 69127 12/16/2015 70377 12/19/2015 67952 12/24/2015 64642 12/26/2015 68630 12/26/2015 71458 12/27/2015 64656 1/5/2016 71965 5/7/2016 72838 5/8/2016 73354 5/12/2016 71966 5/15/2016 68316 9/18/2016 71083 10/28/2016 69577 11/16/2016 71499 12/27/2016 72690 1/14/2017 72222 1/25/2017 73248 3/5/2017 73815 4/30/2017 75445 5/13/2017 75892 7/8/2017 76336 7/17/2017 78746 8/6/2017 80739 8/7/2017 76447 8/7/2017 78102 8/15/2017 78417 9/30/2017 77353 10/1/2017 78847 11/9/2017 78648 1/9/2018 78946 1/25/2018 80448 2/28/2018
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0193-2017
Related Recalls
Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter (Namic RA Syringes) Angio Pack Part numbers AMS6908E, AMS6908F
Windstone Medical Packaging
Affected kits contain Medline Namic RA Syringes, which are recalled by their manufacturer due to risk of syringe rotating adapter unwinding during use, which may result in a loose connection or full disconnection between syringe and manifold. If unwinding occurs, there is a potential for biohazard exposure, blood loss, infection. or air embolism.
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).