Device product
CHS Custom Convenience Kit-FOERSTER SPONGE FORCEPS, SERR, ST (9.5 ) Product Number:-D36-14623
Z-0244-2019
Product summary
- Event
- Event 81179
- Status
- Terminated
- Classification
- Class II
- Quantity
- 50 units
- Official record key
device-enforcement:Z-0244-2019
Official wording
Reason: Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Code information: Lot number: 52418 Exp. Date: 5/1/2021
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