MICROspecialties, Inc. recalls Synergetics I-Pack Injection Kit with Drape -For use with Ophthalmic injections Model/Catalog Number: 18061

Recall date

June 5, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2334-2024

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 Drape -For use with Ophthalmic injections Model/Catalog Number: 18061