Reported Mar 8, 2017 · Terminated
ENT Pack, part number AMS3237(A ENT Pack, part number AMS4214
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?
ENT Packpart number AMS3237(A ENT Packpart number AMS4214
- Lot codes and dates
Lot number and expiration date 845305/25/2018 845885/12/2018 851397/14/2018 856558/1/2018 863109/26/2018 864809/3/2018 867499/21/2018 872878/11/2019 881849/4/2018 8831811/19/2018 8864710/5/2018 894959/30/2019 8958912/10/2018 951031/2/2019 961941/18/2019 969225/11/2019 977876/9/2019 986766/27/2019
- Amount recalled
- 390 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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