—#130706

Product

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

FDA product code: KRA — Catheter, Continuous Flush
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K082613
Affected lot / code info: Catalog No: 28MC24130ST, Lot H665694, H669824, Exp 2017 and Catalog No: 28MC24150SN, Lot H665696, Exp 7/31/2014

Why it was recalled

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

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

Consignees were notified via letter on September 26, 2014. Written notification included product identification information, instruction to immediately quarantine any devices and discontinue use, ensure all personnel to whom devices were distributed are made aware of this field action, and instructions to contact their Merit representative. An email notification was sent to US Merit sales representatives with accounts that had received affected product. The affected sales representatives were provided a Customer Response Form applicable to their account, a representative copy of communications sent directly to their affected accounts, and a copy of the Frequently Asked Questions. Merit sales representatives were instructed to visit the account and assist with the return of the affected units back to the Merit Field Assurance Department.

Recalling firm

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

Distribution

Distribution pattern: Nationwide and to India. No govt/military/VA consignees.

Timeline

Recall initiated: 2014-09-26
Posted by FDA: 2014-10-31
Terminated: 2014-11-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #130706. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.