Minor Pack AMS1374(A, CMP1560, PSS3517, PSS3517(A, PSS3518, PSS3518(A, PSS3541, and PSS3541(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: 59360 4/4/2015 60180 7/22/2015 60972 8/20/2015 60716 9/20/2015 61627 10/15/2015 65729 11/15/2015 65371 11/18/2015 62925 11/26/2015 64759 12/26/2015 63807 1/14/2016 64511 1/16/2016 65907 7/11/2016 57777 7/16/2016 67561 8/26/2016 69460 9/11/2016 69554 11/9/2016 72302 1/5/2017 71984 1/27/2017 73801 4/2/2017 74579 4/23/2017 78211 4/26/2017 74831 5/23/2017 74685 5/24/2017 74462 5/25/2017 74578 5/26/2017 75514 7/2/2017 77373 7/19/2017 78511 8/6/2017 75602 9/19/2017 79095 11/4/2017 79588 11/20/2017 79682 1/17/2018 79251 1/26/2018 81260 2/13/2018 80649 2/27/2018
- 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:
Minor Pack AMS1374(A, CMP1560, PSS3517, PSS3517(A, PSS3518, PSS3518(A, PSS3541, and PSS3541(A. convenience custom kits used for general surgery in hospital operating room
Product Codes/Lot Numbers:
Lot Numbers/Expiration Dates: 59360 4/4/2015 60180 7/22/2015 60972 8/20/2015 60716 9/20/2015 61627 10/15/2015 65729 11/15/2015 65371 11/18/2015 62925 11/26/2015 64759 12/26/2015 63807 1/14/2016 64511 1/16/2016 65907 7/11/2016 57777 7/16/2016 67561 8/26/2016 69460 9/11/2016 69554 11/9/2016 72302 1/5/2017 71984 1/27/2017 73801 4/2/2017 74579 4/23/2017 78211 4/26/2017 74831 5/23/2017 74685 5/24/2017 74462 5/25/2017 74578 5/26/2017 75514 7/2/2017 77373 7/19/2017 78511 8/6/2017 75602 9/19/2017 79095 11/4/2017 79588 11/20/2017 79682 1/17/2018 79251 1/26/2018 81260 2/13/2018 80649 2/27/2018
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0242-2017
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Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A
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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).