Device product
Synergetics I-Pack Injection Kit with Drape -For use with Ophthalmic injections Model/Catalog Number: 18061
Z-2334-2024
Product summary
- Event
- Event 94794
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 96 units
- Official record key
device-enforcement:Z-2334-2024
Official wording
Reason: Could not confirm products were exposed to the proper sterilization cycle can potentially cause post operative wound infection or injection site infection.
Code information: UDI: 10841305101071 LOT: P63044983R
Distribution pattern: MO
Derived failure modes
-
Unknown
Could not confirm products were exposed to the proper sterilization cycle can potentially cause post operative wound infection or injection site infection.