Reported Oct 26, 2016 · Terminated
Minor Tray AMS2685 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?
- Minor Tray AMS2685 convenience custom kits used for general surgery in hospital operating room
- Lot codes and dates
- Lot Numbers/Expiration Dates
645091/4/2016631841/24/2016688249/2/2016695509/5/2016719601/2/2017729523/12/2017736884/5/2017735994/20/2017745505/7/2017747825/22/2017756507/29/2017804418/9/2017783299/23/20177667910/4/2017787421/4/2018
- Lot Numbers/Expiration Dates
- Amount recalled
- 600 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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