Reported Oct 26, 2016 · Terminated
Hand Pack, Kit number 009651-3, AMS1371(B, AMS1539, AMS1539(A, AMS3640, AMS3847, AMS4213, AMS4311, PSS1843(A,…
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?
- Hand Pack, Kit number 009651-3, AMS1371(B, AMS1539, AMS1539(A, AMS3640, AMS3847, AMS4213, AMS4311, PSS1843(A, PSS2153(B, PSS2187(B, PSS2351, and PSS3073. convenience custom kits used for general surgery in hospital operating room
- Lot codes and dates
- Lot codes/Expiration dates
338 of 338 codes
650133/1/2014582613/20/2014589643/27/2014618574/10/2014609684/20/2014570954/25/2014590025/2/2014603885/5/2014602996/30/2014627988/21/20146265410/25/20146444712/5/20146307212/9/20146432812/13/20146467912/18/20146336812/20/2014637991/13/2015666442/2/2015665092/14/2015657772/25/2015655732/25/2015657182/28/2015658753/6/2015655723/15/2015590273/26/2015586924/5/2015686134/12/2015671754/14/2015572494/20/2015680694/28/2015
- Lot codes/Expiration dates
- Amount recalled
- 8132 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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