Arthroscopy Pack, Kit numbers AMS2938, AMS3639, PSS1592(B, PSS1799, and PSS1845(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: 66444 2/5/2015 73046 1/1/2016 74702 3/18/2016 73595 4/17/2016 78038 7/30/2016 76691 9/1/2016 78555 9/11/2016 78554 10/19/2016 56085 6/6/2016 59697 8/1/2015 67248 7/16/2016 68753 9/12/2016 69101 9/3/2016 78129 8/23/2017 80761 2/1/2018 60666 10/19/2014 59667 7/19/2015 60265 7/19/2015 60266 7/22/2015 60267 7/24/2015 61386 8/20/2015 60268 8/25/2015 60269 8/26/2015 61384 9/17/2015 61385 9/27/2015 61388 10/13/2015 61389 10/15/2015 65208 10/19/2015 61387 11/7/2015 63013 11/14/2015 65740 11/15/2015 65803 11/17/2015 64600 11/20/2015 61979 11/21/2015 61980 11/22/2015 63012 12/9/2015 63014 12/18/2015 63231 12/19/2015 65902 12/24/2015 63993 1/16/2016 57069 5/21/2016 57629 6/24/2016 58257 7/20/2016 58321 7/24/2016 67609 7/24/2016 58463 7/25/2016 77994 7/30/2016 58936 8/21/2016 58938 8/22/2016 59058 8/23/2016 68288 9/3/2016 69711 9/18/2016 68756 9/22/2016 70300 9/23/2016 70300 9/23/2016 68287 9/24/2016 70569 9/24/2016 68757 9/25/2016 70769 9/28/2016 70299 10/22/2016 71130 12/17/2016 72509 1/15/2017 72796 1/16/2017 72081 1/21/2017 72319 1/21/2017 73779 1/23/2017 73412 3/21/2017 72961 3/22/2017 73089 3/23/2017 73549 4/15/2017 74273 4/19/2017 74274 4/20/2017 74275 4/23/2017 74276 4/23/2017 74410 4/24/2017 76487 4/24/2017 76884 4/24/2017 74823 5/23/2017 74824 5/23/2017 75046 5/24/2017 75205 5/24/2017 75352 6/21/2017 75675 6/21/2017 76278 7/19/2017 76277 7/24/2017 76885 7/24/2017 78352 9/14/2017 78133 9/29/2017 78952 11/21/2017 80544 1/18/2018 79605 1/23/2018 70570 1/24/2018 81269 2/14/2018 60229 5/18/2014 61713 8/5/2014 62412 10/12/2014 62622 12/4/2014 63424 12/3/2014 63758 1/18/2015 64012 12/11/2014 66920 2/21/2015 67462 4/4/2015 68759 4/5/2015 69468 9/28/2015 70973 11/20/2015 72097 12/24/2015 73763 3/9/2016 74313 4/25/2016 75999 5/24/2016 77194 11/30/2016 79795 2/26/2017
- 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:
Arthroscopy Pack, Kit numbers AMS2938, AMS3639, PSS1592(B, PSS1799, and PSS1845(A. convenience custom kits used for general surgery in hospital operating room
Product Codes/Lot Numbers:
Lot Numbers/ Expiration Dates: 66444 2/5/2015 73046 1/1/2016 74702 3/18/2016 73595 4/17/2016 78038 7/30/2016 76691 9/1/2016 78555 9/11/2016 78554 10/19/2016 56085 6/6/2016 59697 8/1/2015 67248 7/16/2016 68753 9/12/2016 69101 9/3/2016 78129 8/23/2017 80761 2/1/2018 60666 10/19/2014 59667 7/19/2015 60265 7/19/2015 60266 7/22/2015 60267 7/24/2015 61386 8/20/2015 60268 8/25/2015 60269 8/26/2015 61384 9/17/2015 61385 9/27/2015 61388 10/13/2015 61389 10/15/2015 65208 10/19/2015 61387 11/7/2015 63013 11/14/2015 65740 11/15/2015 65803 11/17/2015 64600 11/20/2015 61979 11/21/2015 61980 11/22/2015 63012 12/9/2015 63014 12/18/2015 63231 12/19/2015 65902 12/24/2015 63993 1/16/2016 57069 5/21/2016 57629 6/24/2016 58257 7/20/2016 58321 7/24/2016 67609 7/24/2016 58463 7/25/2016 77994 7/30/2016 58936 8/21/2016 58938 8/22/2016 59058 8/23/2016 68288 9/3/2016 69711 9/18/2016 68756 9/22/2016 70300 9/23/2016 70300 9/23/2016 68287 9/24/2016 70569 9/24/2016 68757 9/25/2016 70769 9/28/2016 70299 10/22/2016 71130 12/17/2016 72509 1/15/2017 72796 1/16/2017 72081 1/21/2017 72319 1/21/2017 73779 1/23/2017 73412 3/21/2017 72961 3/22/2017 73089 3/23/2017 73549 4/15/2017 74273 4/19/2017 74274 4/20/2017 74275 4/23/2017 74276 4/23/2017 74410 4/24/2017 76487 4/24/2017 76884 4/24/2017 74823 5/23/2017 74824 5/23/2017 75046 5/24/2017 75205 5/24/2017 75352 6/21/2017 75675 6/21/2017 76278 7/19/2017 76277 7/24/2017 76885 7/24/2017 78352 9/14/2017 78133 9/29/2017 78952 11/21/2017 80544 1/18/2018 79605 1/23/2018 70570 1/24/2018 81269 2/14/2018 60229 5/18/2014 61713 8/5/2014 62412 10/12/2014 62622 12/4/2014 63424 12/3/2014 63758 1/18/2015 64012 12/11/2014 66920 2/21/2015 67462 4/4/2015 68759 4/5/2015 69468 9/28/2015 70973 11/20/2015 72097 12/24/2015 73763 3/9/2016 74313 4/25/2016 75999 5/24/2016 77194 11/30/2016 79795 2/26/2017
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0142-2017
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).