FDAFDA · Food and drugs·Recall number Z-0206-2017
Head and Neck Pack, kit numbers AMS1373(A, AMS1869, AMS2534, and AMS2534(A. convenience custom kits used for general surgery in hospital operating room
Published October 26, 2016 · Recall initiated: April 22, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Windstone Medical Packaging, Inc.
- Distributor
- Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.
- Lot
- Lot Numbers/ Expiration Dates: 62890 3/28/2014 61286 5/28/2014 61286 5/28/2014 59473 4/20/2015 59560 7/3/2015 60355 7/17/2015 60356 7/22/2015 60357 7/23/2015 60452 8/29/2015 61629 9/3/2015 60755 10/3/2015 61443 10/19/2015 65058 11/1/2015 64558 11/6/2015 65918 11/13/2015 66516 11/15/2015 65281 11/16/2015 61558 11/17/2015 62751 11/21/2015 64660 11/21/2015 62752 11/25/2015 61971 11/29/2015 64624 11/30/2015 72235 12/3/2015 67959 12/12/2015 69436 12/16/2015 68587 12/21/2015 69183 12/21/2015 71969 12/21/2015 65701 12/23/2015 67341 12/26/2015 70809 12/26/2015 62944 1/8/2016 72839 5/8/2016 57471 6/5/2016 57615 6/26/2016 68222 7/5/2016 58757 8/9/2016 67888 8/10/2016 59028 8/15/2016 68864 9/19/2016 69701 10/6/2016 69063 10/10/2016 69678 10/23/2016 69679 10/26/2016
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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