Catheter, Continuous Flush The Merit Microcatheter is intended for general intravascular use, including peripheral and c

FDA device recall Z-0614-2014 · posted 2013-12-31 · Terminated

Recall details

Recalling firm

Merit Medical Systems, Inc.

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.

Action taken

Merit Medical Systems sent an Urgent Product Recall Notice dated December 6, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use of the Maestro Microcatheters identified and isolate them in a quarantined area until the product is over-labeled by their Merit Sales Representative Customers were instructed to ensure that all personnel to whom the devices were distributed were made aware of the field action. Customers with questions were instructed to contact their sales representative or call 1-801-826-4062. For questions regarding this recall call 801-253-1600.

Root cause

Packaging process control

Status

Terminated

Product code

KRA

Quantity affected

59

Distribution

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

Date initiated

2013-12-06

Date posted

2013-12-31

Date terminated

2014-01-27

Location

South Jordan, UT

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