Device product
Custom Pack - with Introducer Kit, Kit number TVS4011NI(K and TVS4011NI(L convenience custom kits used for general surgery in hospital operating room
Z-0166-2017
Product summary
- Event
- Event 71968
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1470 kits
- Official record key
device-enforcement:Z-0166-2017
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: 62733 11/3/2015 62734 11/11/2015 63822 11/15/2015 63851 1/1/2016 64256 1/3/2016 64255 1/13/2016 63852 4/2/2016 69318 7/14/2016 69233 7/18/2016 69910 9/17/2016 70959 12/6/2016 70958 1/3/2017 73965 1/9/2017 73697 1/20/2017 73698 1/23/2017 75426 5/18/2017 73966 5/20/2017 76637 6/11/2017 76070 6/30/2017 78670 8/13/2017 78276 9/30/2017
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.