Reported Oct 26, 2016 · Terminated
Breast Augmentation Pack, Kit part number AMS1786, AMS1786(A, AMS2790, AMS3324, AMS3324(A, and PSS3430. convenience…
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?
- Breast Augmentation Pack, Kit part number AMS1786, AMS1786(A, AMS2790, AMS3324, AMS3324(A, and PSS3430. convenience custom kits used for general surgery in hospital operating room
- Lot codes and dates
- Lot numbers/Expiration dates
108 of 108 codes
5927810/2/20135840710/14/20136243612/4/20136292212/18/2013607405/20/2014634676/2/2014620676/7/2014647036/10/2014616196/14/2014641106/14/2014635396/29/2014652717/8/2014653647/11/2014658377/31/2014702469/3/2014703519/4/2014698509/7/2014674009/11/2014694349/18/2014716399/18/2014683109/30/20147294410/1/20147194810/9/20147194910/22/2014658942/7/2015686243/12/2015776008/12/2015762928/14/20157286210/5/20157398910/7/2015
- Lot numbers/Expiration dates
- Amount recalled
- 1498 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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