FDAClass IIMay 19, 2021

Regard Dressing Change Tray recall

Regard Dressing Change Tray

Why was Regard Dressing Change Tray recalled?

ChloraPrep applicators in the kit can grow organisms that can result in a breach of the applicators package integrity.

What should I do if I have this product?

Review the official FDA enforcement record for current 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: 86983C, 87081C and 86356C.

Product
Regard Dressing Change Tray
Recalling firm
ROi CPS LLC
Quantity
272 trays
Distribution
US Nationwide distribution in the state of Louisiana.
Recall date
May 19, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls