Reported Oct 26, 2016 · Terminated
Shoulder Pack, Kit number AMS1372(A, AMS1372(B, AMS2335, AMS2335(A, AMS2936, AMS3638, AMS3711, AMS4212, PSS1852(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?
- Shoulder Pack, Kit number AMS1372(A, AMS1372(B, AMS2335, AMS2335(A, AMS2936, AMS3638, AMS3711, AMS4212, PSS1852(A, convenience custom kits used for general surgery in hospital operating room
- Lot codes and dates
- Lot Number/ Expiration Date(no date was provided)
155 of 155 codes
610691/5/2015574701/15/2015641621/20/2015667921/31/2015613122/27/2015663922/27/2015593274/24/2015600997/15/2015618727/26/2015602778/24/2015602788/24/2015613939/7/2015632019/15/20156139410/14/20156276211/3/20156194011/17/20156215511/23/20156455711/27/20156128011/27/20156127911/28/20156139211/30/20156618412/24/20156527812/27/2015631781/3/2016639941/13/2016646011/13/2016646431/17/2016637821/23/2016637831/23/2016730451/29/2016
- Lot Number/ Expiration Date
- Amount recalled
- 3104 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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