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FDAJune 5, 2024device

Synergetics I-Pack Injection Kit with Drape -For use with Ophthalmic injections Model/Catalog Number: 18061

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

microspecialties

UPCs

10841305101071

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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