Reported Mar 8, 2017 · Terminated
Set-Up Pack, part number PSS1305(C
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 PSS1305(C
- Lot codes and dates
Lot number and expiration date 1002809/22/2019 1011049/14/2019 840896/29/2018 852937/29/2018 858078/21/2018 862099/23/2018 864278/9/2018 866278/11/2019 877349/29/2018 879349/7/2018 8793511/21/2018 8793612/25/2018 8793712/29/2018 894761/28/2019 956461/10/2019 960621/16/2019 964633/8/2019 964646/22/2019 964655/28/2019 964665/29/2019 968076/6/2019 976106/19/2019 976116/17/2019 978789/25/2019 978789/25/2019 991959/14/2019
- Amount recalled
- 1275 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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