Device product
ENT Tray, Kit number AMS1195(A convenience custom kits used for general surgery in hospital operating room
Z-0182-2017
Product summary
- Event
- Event 71968
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1795 kits
- Official record key
device-enforcement:Z-0182-2017
Official wording
Reason: 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.
Code information: Lot Numbers/ Expiration Dates: 59841 7/3/2015 59998 7/22/2015 60492 9/12/2015 61308 9/24/2015 64554 10/19/2015 65916 11/1/2015 65449 11/2/2015 62451 11/6/2015 65563 11/9/2015 63498 11/11/2015 66317 11/12/2015 66528 11/27/2015 62114 11/30/2015 64157 1/7/2016 63818 1/24/2016 68366 7/12/2016 67034 7/15/2016 57296 7/25/2016 78780 7/30/2016 66529 8/26/2016 59011 8/28/2016 69786 9/7/2016 70822 9/13/2016 69209 10/10/2016 71824 12/10/2016 72548 1/17/2017 72194 1/31/2017 73166 3/7/2017 73705 4/2/2017 74465 5/7/2017 74906 5/30/2017 75575 7/3/2017 75725 7/8/2017 76499 7/21/2017 75890 7/29/2017 79088 9/27/2017 76846 10/5/2017
Distribution pattern: Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.
Derived failure modes
-
Unknown
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.