Device product
CHS Custom Convenience Kit-TOENAIL REMOVAL TRAY Product Number: (1) ZZ-0956; (2) ZZ-0685
Z-0253-2019
Product summary
- Event
- Event 81179
- Status
- Terminated
- Classification
- Class II
- Quantity
- 80 units
- Official record key
device-enforcement:Z-0253-2019
Official wording
Reason: Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Code information: Lot number: (1) 71718 Exp. Date: 7/1/2021 (2) 70618 Exp Date: 7/1/2021
Distribution pattern: Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
Derived failure modes
-
Unknown
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility