Device product
Brow Pack, Kit part number PSS1785(A, PSS1785(B, and PSS1785(C. convenience custom kits used for general surgery in hospital operating room
Z-0157-2017
Product summary
- Event
- Event 71968
- Status
- Terminated
- Classification
- Class II
- Quantity
- 288 kits
- Official record key
device-enforcement:Z-0157-2017
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 58933 7/15/2015 57079 7/29/2015 58462 7/31/2015 63011 11/2/2015 64381 11/15/2015 65577 11/30/2015 64599 1/20/2016 70562 9/27/2016 67303 10/26/2016 71405 1/5/2017 72164 1/27/2017 71900 3/19/2018
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.