Shoulder Arthroscopy Pack, Kit number 002648-15, 002648-16, AMS2496, AMS2496(A, AMS2609, PSS2209(A, and PSS2209(B. convenience custom kits used for general surgery in hospital operating room
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Number/ Expiration Date: 59007 8/27/2013 57610 8/31/2013 60128 12/15/2013 62099 12/21/2013 61297 2/9/2014 62189 2/12/2014 57522 4/30/2014 60028 5/12/2014 60303 5/19/2014 61416 8/17/2014 63836 9/7/2014 66799 9/19/2014 61924 12/3/2014 63333 12/8/2014 65167 12/31/2014 67369 2/4/2015 68073 4/17/2015 70983 9/6/2015 70169 9/21/2015 71061 10/10/2015 65331 11/5/2015 62082 11/7/2015 66580 11/20/2015 64544 1/29/2016 68947 2/19/2016 74854 3/23/2016 75534 4/25/2016 69610 5/7/2016 71352 6/17/2016 66677 7/5/2016 67866 7/6/2016 67702 7/30/2016 77629 7/30/2016 78550 7/30/2016 68712 9/13/2016 68215 9/17/2016 79701 10/11/2016 70494 10/17/2016 75648 12/1/2016 71381 12/12/2016 76128 1/22/2017 72479 3/15/2017 72951 3/24/2017 73131 4/15/2017 74758 5/5/2017 73849 5/7/2017 73192 5/30/2017 76672 7/17/2017 80956 8/8/2017 78024 8/23/2017 77684 10/24/2017 79660 1/9/2018 78944 1/16/2018
- 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:
Shoulder Arthroscopy Pack, Kit number 002648-15, 002648-16, AMS2496, AMS2496(A, AMS2609, PSS2209(A, and PSS2209(B. convenience custom kits used for general surgery in hospital operating room
Product Codes/Lot Numbers:
Lot Number/ Expiration Date: 59007 8/27/2013 57610 8/31/2013 60128 12/15/2013 62099 12/21/2013 61297 2/9/2014 62189 2/12/2014 57522 4/30/2014 60028 5/12/2014 60303 5/19/2014 61416 8/17/2014 63836 9/7/2014 66799 9/19/2014 61924 12/3/2014 63333 12/8/2014 65167 12/31/2014 67369 2/4/2015 68073 4/17/2015 70983 9/6/2015 70169 9/21/2015 71061 10/10/2015 65331 11/5/2015 62082 11/7/2015 66580 11/20/2015 64544 1/29/2016 68947 2/19/2016 74854 3/23/2016 75534 4/25/2016 69610 5/7/2016 71352 6/17/2016 66677 7/5/2016 67866 7/6/2016 67702 7/30/2016 77629 7/30/2016 78550 7/30/2016 68712 9/13/2016 68215 9/17/2016 79701 10/11/2016 70494 10/17/2016 75648 12/1/2016 71381 12/12/2016 76128 1/22/2017 72479 3/15/2017 72951 3/24/2017 73131 4/15/2017 74758 5/5/2017 73849 5/7/2017 73192 5/30/2017 76672 7/17/2017 80956 8/8/2017 78024 8/23/2017 77684 10/24/2017 79660 1/9/2018 78944 1/16/2018
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0269-2017
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).