Reported Mar 8, 2017 · Terminated
Open Procedure Pack, part number AMS4596 Open Procedure Pack, part number AMS4596(A Open Procedure Pack, part number…
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?
Open Procedure Packpart number AMS4596 Open Procedure Packpart number AMS4596(A Open Procedure Packpart number AMS4596(B
- Lot codes and dates
Lot number and expiration date 1002066/1/2018 1002487/9/2018 1004387/19/2018 1004398/29/2018 1008539/15/2018 8683210/10/2017 8826810/4/2017 8937711/9/2017 8937812/9/2017 9496712/31/2017 958881/5/2018 961992/11/2018 970181/9/2018 970192/17/2018 971464/28/2018 973013/22/2018 974786/13/2018 981895/20/2018
- Amount recalled
- 1125 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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