FDAClass IIOctober 30, 2013

Merit Medical Performa Angiographic Catheter 5F recall

Merit Medical Performa Angiographic Catheter 5F Multipack. Part numbers 7560-43 and 7560-G3.

Why was Merit Medical Performa Angiographic Catheter 5F recalled?

4 lots of Performa Cardiac Multipacks contain a JR4.0 catheter with a slight variation in tip shape.

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?

Part Number/Lot Number: 7560-43/I663860, 7560-43/I663861, 7560-G3/I664519 and 7560-G3/I666388.

Product
Merit Medical Performa Angiographic Catheter 5F Multipack. Part numbers 7560-43 and 7560-G3.
Recalling firm
Merit Medical Systems, Inc.
Quantity
200
Distribution
US Distribution including the states of CO, VA, and MS.
Recall date
October 30, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls