General Plastic Pack, Kit number PSS2432, PSS2432(A, PSS2717, PSS2717(A, and PSS2717(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 Numbers/Expiration Dates: 66206 2/25/2015 61424 8/18/2015 63370 11/2/2015 58543 11/8/2015 65418 11/9/2015 63596 11/11/2015 61749 11/22/2015 63420 1/4/2016 64414 1/9/2016 64968 1/13/2016 56888 5/22/2016 56889 5/23/2016 57341 6/8/2016 68248 7/11/2016 58351 7/14/2016 67619 7/16/2016 67417 8/9/2016 57586 8/14/2016 70741 9/5/2016 70742 9/5/2016 68659 9/21/2016 69502 9/23/2016 70631 9/24/2016 69732 9/26/2016 69073 9/27/2016 68295 9/28/2016 68059 9/29/2016 70630 10/23/2016 71024 12/10/2016 71126 12/17/2016 72093 1/7/2017 70999 1/18/2017 73785 1/27/2017 73806 4/5/2017 73807 4/9/2017 74111 4/10/2017 73618 4/20/2017 76130 7/15/2017 81087 1/9/2018
- 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 Plastic Pack, Kit number PSS2432, PSS2432(A, PSS2717, PSS2717(A, and PSS2717(B. convenience custom kits used for general surgery in hospital operating room
Product Codes/Lot Numbers:
Lot Numbers/Expiration Dates: 66206 2/25/2015 61424 8/18/2015 63370 11/2/2015 58543 11/8/2015 65418 11/9/2015 63596 11/11/2015 61749 11/22/2015 63420 1/4/2016 64414 1/9/2016 64968 1/13/2016 56888 5/22/2016 56889 5/23/2016 57341 6/8/2016 68248 7/11/2016 58351 7/14/2016 67619 7/16/2016 67417 8/9/2016 57586 8/14/2016 70741 9/5/2016 70742 9/5/2016 68659 9/21/2016 69502 9/23/2016 70631 9/24/2016 69732 9/26/2016 69073 9/27/2016 68295 9/28/2016 68059 9/29/2016 70630 10/23/2016 71024 12/10/2016 71126 12/17/2016 72093 1/7/2017 70999 1/18/2017 73785 1/27/2017 73806 4/5/2017 73807 4/9/2017 74111 4/10/2017 73618 4/20/2017 76130 7/15/2017 81087 1/9/2018
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0196-2017
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).