FDAClass IJanuary 10, 2024

Regard Dressing change kit recall

Regard Dressing change kit, Item Number 800026006

Why was Regard Dressing change kit recalled?

ROi CPS manufactured and distributed medical convenience kits with an irrigation solution component which was subsequently recalled by the component manufacturer.

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?

UDI/DI 10194717107873, Lot Numbers: 98283, 97591, 97405, 97081, 96961, 95508, 94769, 94435, 94270

Product
Regard Dressing change kit, Item Number 800026006
Recalling firm
ROi CPS LLC
Quantity
1830 units
Distribution
US Nationwide distribution in the state of Louisiana.
Recall date
January 10, 2024
Classification
Class I
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls