FDAClass IIMay 18, 2022

Regard brand CABG Pack A and B - Spartanburg recall

Regard brand CABG Pack A and B - Spartanburg

Why was Regard brand CABG Pack A and B - Spartanburg recalled?

Kits were packed into shipping boxes incorrectly.

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?

Item Number: 800208017, Lot 91156 UDI: (01)10194717112495(17)230101(10)91156

Product
Regard brand CABG Pack A and B - Spartanburg
Recalling firm
ROi CPS LLC
Quantity
85 kits
Distribution
Recall impacted one domestic consignee in NC
Recall date
May 18, 2022
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls