FDAClass IIDecember 21, 2022

DeRoyal EYE PACK recall

DeRoyal EYE PACK, REF 89-4051.09

Why was DeRoyal EYE PACK recalled?

DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Numbers: Lot 56778647 exp 4/1/2023; Lot 57190263 exp 4/1/2023; Lot 57750460 exp 4/3/2023

Product
DeRoyal EYE PACK, REF 89-4051.09
Recalling firm
DeRoyal Industries Inc
Quantity
156 kits
Distribution
US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi
Recall date
December 21, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls