Minor Ortho Pack, Kit number 002646-12 and 002646-13 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: 59453 8/2/2013 58726 8/21/2013 62658 12/11/2013 63489 12/17/2013 61162 12/21/2013 60183 12/29/2013 65535 1/31/2014 66430 1/31/2014 66807 1/31/2014 61804 2/7/2014 67876 9/5/2014 64144 9/7/2014 64457 9/30/2014 64909 9/30/2014 69781 5/2/2016 68945 5/10/2016 71058 6/4/2016 57425 6/28/2016
- 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:
Minor Ortho Pack, Kit number 002646-12 and 002646-13 convenience custom kits used for general surgery in hospital operating room
Product Codes/Lot Numbers:
Lot Numbers/ Expiration Dates: 59453 8/2/2013 58726 8/21/2013 62658 12/11/2013 63489 12/17/2013 61162 12/21/2013 60183 12/29/2013 65535 1/31/2014 66430 1/31/2014 66807 1/31/2014 61804 2/7/2014 67876 9/5/2014 64144 9/7/2014 64457 9/30/2014 64909 9/30/2014 69781 5/2/2016 68945 5/10/2016 71058 6/4/2016 57425 6/28/2016
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0241-2017
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).