Reported Oct 26, 2016 · Terminated
Set-Up Pack, Kit number PSS1305(B and PSS1305(C convenience custom kits used for general surgery in hospital operating…
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?
- Set-Up Pack, Kit number PSS1305(B and PSS1305(C convenience custom kits used for general surgery in hospital operating room
- Lot codes and dates
- Lot Number/ Expiration Date
64 of 64 codes
6772311/19/20156192811/20/2015566927/19/2016677577/22/2016583058/6/2016583458/14/2016697989/14/2016699229/16/2016699239/29/20165834610/4/20167057810/11/20166874710/12/20166928010/23/20167057912/5/20167058012/26/2016709883/23/2017735584/24/2017743205/24/2017744725/25/2017759897/16/2017771907/21/2017764667/22/2017748507/23/2017768907/23/2017753687/30/2017768918/4/2017769038/10/2017775178/29/2017779879/5/20177736110/10/2017
- Lot Number/ Expiration Date
- Amount recalled
- 2225 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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