Reported Mar 8, 2017 · Terminated
Custom Pack - with Introducer Kit, part number TVS4011NI(L
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 Pack - with Introducer Kit, part number TVS4011NI(L
- Lot codes and dates
Lot number and expiration date 850144/30/2018 854487/14/2018 859378/23/2018 877138/9/2018 8809211/18/2018 8934210/17/2018 8997412/5/2018 9521212/3/2018 9572512/19/2018 9688212/9/2018 970515/27/2019 980885/2/2019 984235/25/2019 988525/14/2019
- Amount recalled
- 840 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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