FDAClass IINovember 12, 2014

Merit Maestro Microcatheter recall

Merit Maestro Microcatheter, 2.4F 130cm Straight, REF28MC24130ST, Rx Only, Non-pyrogenic Sterile if package is unopened or undamaged.

Why was Merit Maestro Microcatheter recalled?

These microcatheters were packaged with a 2.8 F distal tip, rather than the labeled 2.4 F.

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 No: 28MC24130ST, Lot H665694, H669824, Exp 2017 and Catalog No: 28MC24150SN, Lot H665696, Exp 7/31/2014

Product
Merit Maestro Microcatheter, 2.4F 130cm Straight, REF28MC24130ST, Rx Only, Non-pyrogenic Sterile if package is unopened or undamaged.
Recalling firm
Merit Medical Systems, Inc.
Quantity
56 units
Distribution
Nationwide and to India. No govt/military/VA consignees.
Recall date
November 12, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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