Synergetics I Pack Injection Kit Custom-Tray for use with Ophthalmic injections Model/Catalog Nu...
FDA Recall #Z-2335-2024 — Class II — June 5, 2024
Product Description
Synergetics I Pack Injection Kit Custom-Tray for use with Ophthalmic injections Model/Catalog Number: 18069 Product Description:
Reason for Recall
Could not confirm products were exposed to the proper sterilization cycle can potentially cause post operative wound infection or injection site infection.
Recalling Firm
MICROspecialties, Inc. — Middletown, CT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
780 units
Distribution
MO
Code Information
UDI 10841305101125 LOT: P62764965R
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated