Reported Oct 26, 2016 · Terminated
Custom Pack - with Introducer Kit, Kit number TVS4011NI(K and TVS4011NI(L 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 Pack - with Introducer Kit, Kit number TVS4011NI(K and TVS4011NI(L convenience custom kits used for general surgery in hospital operating room
- Lot codes and dates
- Lot Numbers/ Expiration Dates
6273311/3/20156273411/11/20156382211/15/2015638511/1/2016642561/3/2016642551/13/2016638524/2/2016693187/14/2016692337/18/2016699109/17/20167095912/6/2016709581/3/2017739651/9/2017736971/20/2017736981/23/2017754265/18/2017739665/20/2017766376/11/2017760706/30/2017786708/13/2017782769/30/2017
- Lot Numbers/ Expiration Dates
- Amount recalled
- 1470 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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