Reported Oct 26, 2016 · Terminated
C-Section Pack, Kit number 002643-10, 002643-9, and AMS4449 convenience custom kits used for general surgery in…
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?
- C-Section Pack, Kit number 002643-10, 002643-9, and AMS4449 convenience custom kits used for general surgery in hospital operating room
- Lot codes and dates
- Lot Numbers/ Expiration Dates
582078/31/2013615911/2/2014592281/19/2014665221/31/2014617633/5/2014629299/10/2014674859/19/2014676649/21/2014638359/22/2014652909/30/2014569566/18/2016576666/23/20167106010/13/20166894310/26/20167906511/9/2017798421/25/2018809082/15/2018
- Lot Numbers/ Expiration Dates
- Amount recalled
- 268 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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