Reported Oct 26, 2016 · Terminated
Plastic Pack , Kit number AMS1833(A convenience custom kits used for general surgery in hospital operating room
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?
- Plastic Pack , Kit number AMS1833(A convenience custom kits used for general surgery in hospital operating room
- Lot codes and dates
- Lot Number/ Expiration Date
589873/10/2014651246/13/2014635946/30/2014653837/3/2014679369/16/2014686579/20/2014672809/27/2014761806/10/2016576026/18/2016785297/30/2016592428/27/20168064511/19/2016
- Lot Number/ Expiration Date
- Amount recalled
- 204 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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