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

FDA device recall Z-0162-2015 · posted 2014-10-31 · Terminated

Recall details

Recalling firm

Merit Medical Systems, Inc.

Reason for recall

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

Action taken

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.

Root cause

Mixed-up of materials/components

Status

Terminated

Product code

KRA

Quantity affected

56 units

Distribution

Nationwide and to India. No govt/military/VA consignees.

Date initiated

2014-09-26

Date posted

2014-10-31

Date terminated

2014-11-19

Location

South Jordan, UT

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