Device product
Surgical Suture Kit
Z-1132-2022
Product summary
- Event
- Event 90059
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 7340 units
- Official record key
device-enforcement:Z-1132-2022
Official wording
Reason: There is uncertainty about the integrity of the methods used to ensure the sterile barrier integrity.
Code information: Part Number: ZZ-0958; Primary DI Number: M752ZZ09580; Lot Numbers: 213639474, 212957814, 212675717
Distribution pattern: US Distribution to NC.
Derived failure modes
-
Unknown
There is uncertainty about the integrity of the methods used to ensure the sterile barrier integrity.