Device product
Custom Breast Augmentation Pack, Kit number PSS2455(B, PSS2455(C, PSS2455(D convenience custom kits used for general surgery in hospital operating room
Z-0164-2017
Product summary
- Event
- Event 71968
- Status
- Terminated
- Classification
- Class II
- Quantity
- 546 kits
- Official record key
device-enforcement:Z-0164-2017
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: 62743 8/18/2013 57375 9/5/2013 58352 9/13/2013 58985 1/28/2014 62106 7/14/2014 61743 7/21/2014 63397 12/21/2014 63273 12/26/2014 64371 3/13/2015 64329 3/21/2015 66935 4/22/2015 67471 5/11/2015 68296 9/19/2015 68614 9/27/2015 68614 9/27/2015 70876 10/12/2015 69816 10/14/2015 70681 10/20/2015 71211 10/21/2015 71695 10/26/2015 73064 12/20/2015 72359 12/24/2015 77377 1/19/2016 76155 1/25/2016 81170 7/8/2016
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.