FDAClass IIDecember 21, 2022

Deroyal Major Oral Pack RF recall

DeRoyal MAJOR ORAL PACK RF, REF 89-3936.15

Why was Deroyal Major Oral Pack RF 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 56185163 exp 2/1/2024; Lot 56390466 exp 2/1/2024; Lot 56616859 exp 2/1/2024; Lot 57390901 exp 1/1/2024; Lot 57466813 exp 10/1/2024; Lot 57589987 exp 6/1/2024; Lot 57674444 exp 6/1/2024

Product
DeRoyal MAJOR ORAL PACK RF, REF 89-3936.15
Recalling firm
DeRoyal Industries Inc
Quantity
828 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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