Reported Oct 26, 2016 · Terminated
Minor Pack AMS1374(A, CMP1560, PSS3517, PSS3517(A, PSS3518, PSS3518(A, PSS3541, and PSS3541(A. convenience custom kits…
Windstone Medical Packaging, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Windstone Medical Packaging, Inc. · 1602 4th Ave N · Billings, MT · 59101-1521
Is this the product you have?
- 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
- Lot codes and dates
- Lot Numbers/Expiration Dates
70 of 70 codes
593604/4/2015601807/22/2015609728/20/2015607169/20/20156162710/15/20156572911/15/20156537111/18/20156292511/26/20156475912/26/2015638071/14/2016645111/16/2016659077/11/2016577777/16/2016675618/26/2016694609/11/20166955411/9/2016723021/5/2017719841/27/2017738014/2/2017745794/23/2017782114/26/2017748315/23/2017746855/24/2017744625/25/2017745785/26/2017755147/2/2017773737/19/2017785118/6/2017756029/19/20177909511/4/2017
- Lot Numbers/Expiration Dates
- Amount recalled
- 1025 kits
This recall covers 150 products
The agency filed one notice per product. You are reading one of them; the other 149 are below.
137 more are in the archive.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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