Reported Oct 26, 2016 · Terminated
Laparotomy Pack, Kit number 006047-2, 006268-8, 006268-9, AMS4418, PSS2154, PSS2190, and PSS2190(A. convenience custom…
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?
- Laparotomy Pack, Kit number 006047-2, 006268-8, 006268-9, AMS4418, PSS2154, PSS2190, and PSS2190(A. convenience custom kits used for general surgery in hospital operating room
- Lot codes and dates
- Lot numbers/Expiration dates
114 of 114 codes
579683/10/2014583353/26/2014570963/30/2014599156/16/2014589666/19/2014617318/7/2014632408/21/2014610249/17/2014614999/22/2014635882/11/2015657722/25/2015657792/26/2015642252/28/2015652393/20/2015666457/20/2015680708/4/2015588308/5/2015688938/12/2015682658/17/2015595418/30/2015606509/1/20156980610/6/20155984011/9/2015638111/18/2016737662/2/2016728072/7/2016719172/9/2016734242/15/2016725152/15/2016734012/15/2016
- Lot numbers/Expiration dates
- Amount recalled
- 1528 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.
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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