Device product
CHS Custom Convenience Kit-DR. NANDA CLOSING TRAY(CONMED HYFRECATOR SHARP) Product Number: B9-15934B
Z-0240-2019
Product summary
- Event
- Event 81179
- Status
- Terminated
- Classification
- Class II
- Quantity
- 200 units
- Official record key
device-enforcement:Z-0240-2019
Official wording
Reason: Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Code information: Lot Number: 70618 Exp. Date: 9/1/2020
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