Reported Oct 26, 2016 · Terminated
Breast Pack, Kit part number AMS3238, AMS3238(A, AMS3691, AMS4419, PSS1541, PSS1784, PSS1784(A, PSS1784(B, PSS2272, and…
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?
- Breast Pack, Kit part number AMS3238, AMS3238(A, AMS3691, AMS4419, PSS1541, PSS1784, PSS1784(A, PSS1784(B, PSS2272, and PSS2272(A. convenience custom kits used for general surgery in hospital operating room
- Lot codes and dates
- Lot Numbers/ Expiration Dates
595723/1/2015589324/24/2015570787/8/2015576947/14/2015606208/4/20156176811/4/20156741411/16/2015650341/17/2016751894/16/2016768054/17/2016573726/19/2016576366/20/2016666257/29/2016672959/27/2016710829/28/20167140412/21/2016728261/16/2017721621/27/2017756616/18/2017768897/16/2017770667/19/2017810261/13/2018796381/9/2019
- Lot Numbers/ Expiration Dates
- Amount recalled
- 505 kits
This recall covers 150 products
The agency filed one notice per product. You are reading one of them; the other 149 are below.
137 more are in the archive.
Where it was sold
Why it was recalled
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit 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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