FDAClass IINovember 30, 2022

regard SPINE recall

regard SPINE , NU00974F, Item Number 800769006; neuro surgery convenience kit

Why was regard SPINE recalled?

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

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 10194717114062, Lot Numbers: 91584, exp 9/23/2023

Product
regard SPINE , NU00974F, Item Number 800769006; neuro surgery convenience kit
Recalling firm
ROi CPS LLC
Quantity
21 kits
Distribution
LA, MO, NC, FL
Recall date
November 30, 2022
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls