Reported Mar 8, 2017 · Terminated
Set Up Pack, part number PSS3574(A
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?
- Set Up Pack, part number PSS3574(A
- Lot codes and dates
Lot number and expiration date 1004908/7/2019 849695/27/2018 853416/15/2018 855666/8/2018 869268/2/2018 869277/16/2018 8726310/10/2018 8964711/23/2018 8991310/2/2018 9488911/28/2018 9515611/14/2018 9567412/27/2018 960881/25/2019 968493/7/2019 969905/7/2019 976375/27/2019 980735/23/2019 983735/30/2019 994446/24/2019
- Amount recalled
- 820 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.
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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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