Laparotomy Pack, Kit number 006047-2, 006268-8, 006268-9, AMS4418, PSS2154, PSS2190, and PSS2190(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: 57968 3/10/2014 58335 3/26/2014 57096 3/30/2014 59915 6/16/2014 58966 6/19/2014 61731 8/7/2014 63240 8/21/2014 61024 9/17/2014 61499 9/22/2014 63588 2/11/2015 65772 2/25/2015 65779 2/26/2015 64225 2/28/2015 65239 3/20/2015 66645 7/20/2015 68070 8/4/2015 58830 8/5/2015 68893 8/12/2015 68265 8/17/2015 59541 8/30/2015 60650 9/1/2015 69806 10/6/2015 59840 11/9/2015 63811 1/18/2016 73766 2/2/2016 72807 2/7/2016 71917 2/9/2016 73424 2/15/2016 72515 2/15/2016 73401 2/15/2016 72806 2/28/2016 74679 4/11/2016 74853 5/15/2016 71892 6/1/2016 74680 6/1/2016 71726 6/11/2016 72656 6/16/2016 57461 6/23/2016 57174 7/11/2016 58034 7/11/2016 76085 8/4/2016 58492 8/8/2016 58502 8/13/2016 76923 8/24/2016 78168 9/5/2016 79609 9/9/2016 78573 9/27/2016 70930 9/28/2016 71324 10/19/2016 73071 1/29/2017 74331 5/1/2017 75004 5/4/2017 75545 7/16/2017 77174 7/20/2017 79653 8/7/2017 78409 8/12/2017 79636 1/9/2019
- 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:
Laparotomy Pack, Kit number 006047-2, 006268-8, 006268-9, AMS4418, PSS2154, PSS2190, and PSS2190(A. convenience custom kits used for general surgery in hospital operating room
Product Codes/Lot Numbers:
Lot numbers/Expiration dates: 57968 3/10/2014 58335 3/26/2014 57096 3/30/2014 59915 6/16/2014 58966 6/19/2014 61731 8/7/2014 63240 8/21/2014 61024 9/17/2014 61499 9/22/2014 63588 2/11/2015 65772 2/25/2015 65779 2/26/2015 64225 2/28/2015 65239 3/20/2015 66645 7/20/2015 68070 8/4/2015 58830 8/5/2015 68893 8/12/2015 68265 8/17/2015 59541 8/30/2015 60650 9/1/2015 69806 10/6/2015 59840 11/9/2015 63811 1/18/2016 73766 2/2/2016 72807 2/7/2016 71917 2/9/2016 73424 2/15/2016 72515 2/15/2016 73401 2/15/2016 72806 2/28/2016 74679 4/11/2016 74853 5/15/2016 71892 6/1/2016 74680 6/1/2016 71726 6/11/2016 72656 6/16/2016 57461 6/23/2016 57174 7/11/2016 58034 7/11/2016 76085 8/4/2016 58492 8/8/2016 58502 8/13/2016 76923 8/24/2016 78168 9/5/2016 79609 9/9/2016 78573 9/27/2016 70930 9/28/2016 71324 10/19/2016 73071 1/29/2017 74331 5/1/2017 75004 5/4/2017 75545 7/16/2017 77174 7/20/2017 79653 8/7/2017 78409 8/12/2017 79636 1/9/2019
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0222-2017
Related Recalls
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Windstone Medical Packaging
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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).