Medical device recalls Moderate risk

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

Recall date
June 5, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2336-2024
FDA classification
Class II
Brand / firm
MICROspecialties, Inc.
Sold / distributed
MO

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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