FDAClass IIDecember 21, 2022

Deroyal Cardiac Linen Pack recall

DeRoyal CARDIAC LINEN PACK, REF 89-10543.02

Why was Deroyal Cardiac Linen Pack recalled?

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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 56336988 exp 11/1/2023; Lot 57188770 exp 8/1/2024; Lot 57393440 exp 5/1/2024; Lot 57644325 exp 7/1/2024

Product
DeRoyal CARDIAC LINEN PACK, REF 89-10543.02
Recalling firm
DeRoyal Industries Inc
Quantity
204 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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