Synergetics I Pack Injection Kit- Tray for use with Ophthalmic injections Model/Catalog Numbe...

FDA Recall #Z-2333-2024 — Class II — June 5, 2024

Recall #Z-2333-2024 Date: June 5, 2024 Classification: Class II Status: Ongoing

Product Description

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

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

2316 units

Distribution

MO

Code Information

UDI: 10841305101064 LOT: P62764979R

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated