Extremity Pack, Kit number AMS2726, AMS2937, AMS3240, PSS1381(A PSS1381(B, PSS1798(A, PSS1842(A, and PSS2706 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: 59926 5/26/2014 60668 8/14/2014 70310 1/17/2015 68666 1/20/2015 62745 1/29/2015 69836 2/9/2015 66661 4/25/2015 59586 7/22/2015 60264 7/23/2015 59204 8/5/2015 61382 8/20/2015 63063 9/4/2015 61012 9/11/2015 61013 9/14/2015 64817 10/10/2015 61618 10/15/2015 61383 10/18/2015 64593 10/19/2015 64969 11/3/2015 65776 11/5/2015 64394 11/14/2015 63778 11/15/2015 65580 11/16/2015 61938 11/17/2015 62567 11/18/2015 61626 11/20/2015 66917 11/21/2015 61343 11/22/2015 66393 11/23/2015 62154 11/23/2015 66584 11/26/2015 63230 12/18/2015 66183 12/24/2015 64380 1/4/2016 63989 1/7/2016 63404 1/9/2016 78771 1/9/2016 63992 1/11/2016 64696 1/13/2016 64395 1/14/2016 63779 1/18/2016 73914 3/2/2016 73298 3/16/2016 73714 3/23/2016 56866 5/22/2016 57094 5/23/2016 57068 5/24/2016 77013 6/4/2016 70913 6/6/2016 74518 6/8/2016 57067 6/10/2016 71703 6/14/2016 57216 6/19/2016 76121 6/21/2016 57511 6/22/2016 67763 7/1/2016 69284 7/16/2016 70977 7/17/2016 72321 7/17/2016 58092 7/20/2016 67097 7/23/2016 58319 7/25/2016 77988 7/30/2016 77053 7/30/2016 78132 7/30/2016 77721 7/30/2016 58935 8/21/2016 59057 8/22/2016 57588 8/23/2016 72894 8/25/2016 68286 8/25/2016 59210 8/28/2016 70323 9/11/2016 68755 9/22/2016 69925 9/22/2016 70567 9/24/2016 68888 9/26/2016 70568 9/28/2016 77749 10/21/2016 70298 10/23/2016 69708 10/24/2016 71084 10/28/2016 69471 10/31/2016 69083 11/24/2016 71424 12/11/2016 72789 1/10/2017 72318 1/10/2017 70981 1/21/2017 72960 1/21/2017 73548 1/22/2017 73097 3/13/2017 73917 4/18/2017 74272 4/24/2017 74822 5/14/2017 75045 5/24/2017 74474 5/25/2017 75351 6/20/2017 77597 7/19/2017 75822 7/23/2017 76486 7/27/2017 74084 8/4/2017 76956 8/7/2017 79077 9/10/2017 78131 9/19/2017 77601 10/9/2017 77531 10/10/2017 78761 11/5/2017 78757 11/9/2017 79263 11/23/2017 78470 1/5/2018 79339 1/16/2018 80751 1/23/2018 79337 1/25/2018 79604 2/25/2018 80517 2/25/2018
- 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:
Extremity Pack, Kit number AMS2726, AMS2937, AMS3240, PSS1381(A PSS1381(B, PSS1798(A, PSS1842(A, and PSS2706 convenience custom kits used for general surgery in hospital operating room
Product Codes/Lot Numbers:
Lot Numbers/Expiration Dates: 59926 5/26/2014 60668 8/14/2014 70310 1/17/2015 68666 1/20/2015 62745 1/29/2015 69836 2/9/2015 66661 4/25/2015 59586 7/22/2015 60264 7/23/2015 59204 8/5/2015 61382 8/20/2015 63063 9/4/2015 61012 9/11/2015 61013 9/14/2015 64817 10/10/2015 61618 10/15/2015 61383 10/18/2015 64593 10/19/2015 64969 11/3/2015 65776 11/5/2015 64394 11/14/2015 63778 11/15/2015 65580 11/16/2015 61938 11/17/2015 62567 11/18/2015 61626 11/20/2015 66917 11/21/2015 61343 11/22/2015 66393 11/23/2015 62154 11/23/2015 66584 11/26/2015 63230 12/18/2015 66183 12/24/2015 64380 1/4/2016 63989 1/7/2016 63404 1/9/2016 78771 1/9/2016 63992 1/11/2016 64696 1/13/2016 64395 1/14/2016 63779 1/18/2016 73914 3/2/2016 73298 3/16/2016 73714 3/23/2016 56866 5/22/2016 57094 5/23/2016 57068 5/24/2016 77013 6/4/2016 70913 6/6/2016 74518 6/8/2016 57067 6/10/2016 71703 6/14/2016 57216 6/19/2016 76121 6/21/2016 57511 6/22/2016 67763 7/1/2016 69284 7/16/2016 70977 7/17/2016 72321 7/17/2016 58092 7/20/2016 67097 7/23/2016 58319 7/25/2016 77988 7/30/2016 77053 7/30/2016 78132 7/30/2016 77721 7/30/2016 58935 8/21/2016 59057 8/22/2016 57588 8/23/2016 72894 8/25/2016 68286 8/25/2016 59210 8/28/2016 70323 9/11/2016 68755 9/22/2016 69925 9/22/2016 70567 9/24/2016 68888 9/26/2016 70568 9/28/2016 77749 10/21/2016 70298 10/23/2016 69708 10/24/2016 71084 10/28/2016 69471 10/31/2016 69083 11/24/2016 71424 12/11/2016 72789 1/10/2017 72318 1/10/2017 70981 1/21/2017 72960 1/21/2017 73548 1/22/2017 73097 3/13/2017 73917 4/18/2017 74272 4/24/2017 74822 5/14/2017 75045 5/24/2017 74474 5/25/2017 75351 6/20/2017 77597 7/19/2017 75822 7/23/2017 76486 7/27/2017 74084 8/4/2017 76956 8/7/2017 79077 9/10/2017 78131 9/19/2017 77601 10/9/2017 77531 10/10/2017 78761 11/5/2017 78757 11/9/2017 79263 11/23/2017 78470 1/5/2018 79339 1/16/2018 80751 1/23/2018 79337 1/25/2018 79604 2/25/2018 80517 2/25/2018
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0183-2017
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).