Reported Mar 8, 2017 · Terminated
Custom Pack, part number AMS4776 Custom Pack, part number AMS4776(A Custom Pack, part number AMS5643 Custom Pack, part…
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?
Custom Packpart number AMS4776 Custom Packpart number AMS4776(A Custom Packpart number AMS5643 Custom Packpart number AMS5643(A Custom Packpart number AMS6012 Custom Packpart number AMS6383 Custom Packpart number PSS2135(B Custom Packpart number PSS2798(B Custom Packpart number PSS2798(C Custom Packpart number PSS3463
- Lot codes and dates
65 of 65 codes
Lot number and expiration date 10008410/2/2019 10067810/22/2019 10068310/13/2019 1007009/5/2019 1007717/9/2019 1007727/23/2019 1011889/6/2019 1015559/9/2019 842535/12/2018 842545/25/2018 843779/10/2018 844935/28/2018 844945/28/2018 844956/22/2018 846817/22/2018 846827/29/2018 848537/22/2018 849196/3/2018 860068/22/2018 861359/29/2018 8685310/31/2018 871628/10/2019 871718/20/2018 8722910/5/2018 8758212/28/2018 8761512/17/2018 880069/23/2018 882279/5/2018 8855911/14/2018 8857311/12/2018 8857411/14/2018 886922/28/2018 8869312/9/2018 8889911/24/2018 8922112/7/2018 8955412/9/2018 895551/6/2019 897621/10/2019 9473111/12/2018 950581/18/2019 950611/13/2019 9547712/7/2018 955101/25/2019 956313/7/2019 956541/10/2019 958746/27/2019 960541/13/2019 963613/10/2019 964581/25/2019 964771/25/2019 964786/23/2019 968346/10/2019 969886/9/2019 970006/29/2019 971665/11/2019 975475/7/2019 978206/7/2019 982306/8/2019 985886/7/2019 98753
- Amount recalled
- 4155 kits
This recall covers 124 products
The agency filed one notice per product. You are reading one of them; the other 123 are below.
111 more are in the archive.
Where it was sold
Why it was recalled
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits 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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