—#124756

Product

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.

FDA product code: KRA — Catheter, Continuous Flush
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K082613
Affected lot / code info: Catalog Numbers: 28MC24110ST with Lot Number: H548211, and Catalog Number: 28MC24130SN with Lot Numbers: H549598, or H553237

Why it was 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.

Root cause (FDA determination)

Packaging process control

Action the firm took

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.

Recalling firm

Firm: Merit Medical Systems, Inc.
Address: 1600 West Merit Parkway, South Jordan, Utah 84095

Distribution

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

Timeline

Recall initiated: 2013-12-06
Posted by FDA: 2013-12-31
Terminated: 2014-01-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #124756. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.