Synergetics I Pack Injection Kit with Wire Speculum- Tray for use in Opthalmic Injection Model/...
FDA Recall #Z-2336-2024 — Class II — June 5, 2024
Product Description
Synergetics I Pack Injection Kit with Wire Speculum- Tray for use in Opthalmic Injection Model/Catalog Number: 18069W
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
804 units
Distribution
MO
Code Information
UDI: 10841305101132 LOT: P62764970R
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated