Hand Tray PSS2365(A, PSS2365(B, PSS2365(C, PSS2365(D PSS2365(E, 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: 62742 2/28/2014 65112 3/23/2014 65816 4/24/2014 56706 5/15/2014 66648 7/21/2014 66649 7/21/2014 66165 7/25/2014 57524 9/1/2014 57338 9/20/2014 57977 9/22/2014 56883 9/24/2014 57057 9/24/2014 57523 9/25/2014 58348 1/3/2015 58349 1/4/2015 59680 1/17/2015 60694 1/24/2015 59678 1/25/2015 59679 1/26/2015 59221 1/28/2015 60104 1/29/2015 61738 4/24/2015 61740 6/11/2015 64688 6/19/2015 63590 6/22/2015 63772 6/22/2015 64002 6/22/2015 61739 6/27/2015 63257 6/28/2015 67941 2/11/2016 69813 3/23/2016 69812 3/26/2016 70306 3/30/2016 70581 3/30/2016 68432 6/1/2016 68433 6/9/2016 68006 6/12/2016 68578 6/13/2016 68008 6/30/2016 68894 6/30/2016 75064 7/30/2016 75200 7/30/2016 75500 7/30/2016 75803 7/30/2016 71902 9/10/2016 70989 9/21/2016 72308 9/24/2016 72754 9/24/2016 71238 9/25/2016 74820 11/9/2016 73337 11/15/2016 73397 11/15/2016 74294 11/24/2016 72983 11/25/2016 73566 11/28/2016 78172 4/16/2017 78171 4/19/2017 77607 4/23/2017 76467 4/24/2017 77068 4/24/2017 78380 4/24/2017 80630 4/24/2017 79474 4/25/2017
- 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.
ā ļø 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:
Hand Tray PSS2365(A, PSS2365(B, PSS2365(C, PSS2365(D PSS2365(E, convenience custom kits used for general surgery in hospital operating room
Product Codes/Lot Numbers:
Lot numbers/Expiration dates: 62742 2/28/2014 65112 3/23/2014 65816 4/24/2014 56706 5/15/2014 66648 7/21/2014 66649 7/21/2014 66165 7/25/2014 57524 9/1/2014 57338 9/20/2014 57977 9/22/2014 56883 9/24/2014 57057 9/24/2014 57523 9/25/2014 58348 1/3/2015 58349 1/4/2015 59680 1/17/2015 60694 1/24/2015 59678 1/25/2015 59679 1/26/2015 59221 1/28/2015 60104 1/29/2015 61738 4/24/2015 61740 6/11/2015 64688 6/19/2015 63590 6/22/2015 63772 6/22/2015 64002 6/22/2015 61739 6/27/2015 63257 6/28/2015 67941 2/11/2016 69813 3/23/2016 69812 3/26/2016 70306 3/30/2016 70581 3/30/2016 68432 6/1/2016 68433 6/9/2016 68006 6/12/2016 68578 6/13/2016 68008 6/30/2016 68894 6/30/2016 75064 7/30/2016 75200 7/30/2016 75500 7/30/2016 75803 7/30/2016 71902 9/10/2016 70989 9/21/2016 72308 9/24/2016 72754 9/24/2016 71238 9/25/2016 74820 11/9/2016 73337 11/15/2016 73397 11/15/2016 74294 11/24/2016 72983 11/25/2016 73566 11/28/2016 78172 4/16/2017 78171 4/19/2017 77607 4/23/2017 76467 4/24/2017 77068 4/24/2017 78380 4/24/2017 80630 4/24/2017 79474 4/25/2017
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0205-2017
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).