ENT Tray, Kit number AMS1195(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: 59841 7/3/2015 59998 7/22/2015 60492 9/12/2015 61308 9/24/2015 64554 10/19/2015 65916 11/1/2015 65449 11/2/2015 62451 11/6/2015 65563 11/9/2015 63498 11/11/2015 66317 11/12/2015 66528 11/27/2015 62114 11/30/2015 64157 1/7/2016 63818 1/24/2016 68366 7/12/2016 67034 7/15/2016 57296 7/25/2016 78780 7/30/2016 66529 8/26/2016 59011 8/28/2016 69786 9/7/2016 70822 9/13/2016 69209 10/10/2016 71824 12/10/2016 72548 1/17/2017 72194 1/31/2017 73166 3/7/2017 73705 4/2/2017 74465 5/7/2017 74906 5/30/2017 75575 7/3/2017 75725 7/8/2017 76499 7/21/2017 75890 7/29/2017 79088 9/27/2017 76846 10/5/2017
- 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:
ENT Tray, Kit number AMS1195(A convenience custom kits used for general surgery in hospital operating room
Product Codes/Lot Numbers:
Lot Numbers/ Expiration Dates: 59841 7/3/2015 59998 7/22/2015 60492 9/12/2015 61308 9/24/2015 64554 10/19/2015 65916 11/1/2015 65449 11/2/2015 62451 11/6/2015 65563 11/9/2015 63498 11/11/2015 66317 11/12/2015 66528 11/27/2015 62114 11/30/2015 64157 1/7/2016 63818 1/24/2016 68366 7/12/2016 67034 7/15/2016 57296 7/25/2016 78780 7/30/2016 66529 8/26/2016 59011 8/28/2016 69786 9/7/2016 70822 9/13/2016 69209 10/10/2016 71824 12/10/2016 72548 1/17/2017 72194 1/31/2017 73166 3/7/2017 73705 4/2/2017 74465 5/7/2017 74906 5/30/2017 75575 7/3/2017 75725 7/8/2017 76499 7/21/2017 75890 7/29/2017 79088 9/27/2017 76846 10/5/2017
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0182-2017
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).