Device product

Synergetics I Pack Injection Kit- Tray for use with Ophthalmic injections Model/Catalog Number: 18060

Z-2333-2024

June 05, 2024

Class II

Product summary

Firm: MICROspecialties, Inc.
Event: Event 94794
Status: Ongoing
Classification: Class II
Quantity: 2316 units
Official record key: device-enforcement:Z-2333-2024

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: 10841305101064 LOT: P62764979R

Distribution pattern: MO

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Could not confirm products were exposed to the proper sterilization cycle can potentially cause post operative wound infection or injection site infection.