MICROspecialties, Inc.: Device Recall

Recall #Z-2336-2024 · 06/05/2024

Class II: Risk

Recall Details

Recall Number
Z-2336-2024
Classification
Class II
Product Type
Device
Recalling Firm
MICROspecialties, Inc.
Status
Ongoing
Date Initiated
06/05/2024
Location
Middletown, CT, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
804 units

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.

Product Description

Synergetics I Pack Injection Kit with Wire Speculum- Tray for use in Opthalmic Injection Model/Catalog Number: 18069W

Distribution Pattern

MO

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.