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Catheter, Continuous Flush The Merit Microcatheter is intended for general intravascular use, in...

FDA Recall #Z-0614-2014 — Class II — December 6, 2013

Recall #Z-0614-2014 Date: December 6, 2013 Classification: Class II Status: Terminated

Product Description

Catheter, Continuous Flush The Merit Microcatheter is intended for general intravascular use, including peripheral and coronary vasculature. Once the subselective region has been accessed, the microcatheter can be used for the controlled and selective infusion of diagnostic, embolic or therapeutic materials into vessels.

Reason for Recall

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.

Recalling Firm

Merit Medical Systems, Inc. — South Jordan, UT

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

59

Distribution

Worldwide Distribution - USA (nationwide) and Internationally to Canada.

Code Information

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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