Device product
Podiatry Kit PSS1040(A, PSS1040(B, and PSS1040(C convenience custom kits used for general surgery in hospital operating room
Z-0264-2017
Product summary
- Event
- Event 71968
- Status
- Terminated
- Classification
- Class II
- Quantity
- 545 kits
- Official record key
device-enforcement:Z-0264-2017
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 Number/ Expiration Date: 63877 2/4/2015 65406 2/26/2015 65972 2/26/2015 64947 10/18/2015 61767 11/13/2015 64379 1/4/2016 63309 1/22/2016 57497 7/1/2016 67411 7/11/2016 58086 7/19/2016 77189 7/30/2016 68577 9/22/2016 69473 10/17/2016 72803 1/16/2017 72989 3/29/2017 73422 4/16/2017 76920 4/23/2017 73577 4/25/2017 74415 5/9/2017 74835 6/18/2017 76482 7/13/2017
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.