FDAClass IJanuary 24, 2024

regard Operative LAP recall

regard Operative LAP, Item Number 800943001; surgical convenience kit

Why was regard Operative LAP recalled?

Surgical convenience kits were manufactured with a component which was subsequently recalled by Nurse Assist.

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 10194717111863, Lot Numbers: 94792, 95613, 96003, 96845

Product
regard Operative LAP, Item Number 800943001; surgical convenience kit
Recalling firm
ROi CPS LLC
Quantity
345 units
Distribution
US distribution to Louisiana
Recall date
January 24, 2024
Classification
Class I
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls