Reported Oct 26, 2016 · Terminated
Custom Breast Augmentation Pack, Kit number PSS2455(B, PSS2455(C, PSS2455(D convenience custom kits used for general…
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?
- Custom Breast Augmentation Pack, Kit number PSS2455(B, PSS2455(C, PSS2455(D convenience custom kits used for general surgery in hospital operating room
- Lot codes and dates
- Lot numbers/Expiration dates
627438/18/2013573759/5/2013583529/13/2013589851/28/2014621067/14/2014617437/21/20146339712/21/20146327312/26/2014643713/13/2015643293/21/2015669354/22/2015674715/11/2015682969/19/2015686149/27/2015686149/27/20157087610/12/20156981610/14/20157068110/20/20157121110/21/20157169510/26/20157306412/20/20157235912/24/2015773771/19/2016761551/25/2016811707/8/2016
- Lot numbers/Expiration dates
- Amount recalled
- 546 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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