FDAClass IIJanuary 8, 2014

Catheter recall

Catheter, Continuous Flush The Merit Microcatheter is intended for general intravascular use, including peripheral and coronary vasculature. Once the…

Why was Catheter recalled?

Merit Medical Systems, Inc. is conducting a recall for 3 lots of Maestro Microcatheters with a graphic discrepancy on the carton/box label end panel. The catheter graphic on the front of the carton box (correct) and the graphic on the end panel (incorrect) do not match.

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?

Catalog Numbers: 28MC24110ST with Lot Number: H548211, and Catalog Number: 28MC24130SN with Lot Numbers: H549598, or H553237

Product
Catheter, Continuous Flush The Merit Microcatheter is intended for general intravascular use, including peripheral and coronary vasculature. Once the…
Recalling firm
Merit Medical Systems, Inc.
Quantity
59
Distribution
Worldwide Distribution - USA (nationwide) and Internationally to Canada.
Recall date
January 8, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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