FDAClass IIDecember 21, 2022

Deroyal Cataract Pack CSM recall

DeRoyal CATARACT PACK CSM, REF 89-6863

Why was Deroyal Cataract Pack CSM 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 55807995 exp 1/1/2023; lot 56029890 exp ***; lot 57001098 exp ***; lot 57198118 exp ***; lot 56613261 exp ***

Product
DeRoyal CATARACT PACK CSM, REF 89-6863
Recalling firm
DeRoyal Industries Inc
Quantity
1220 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)
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