Merit Maestro Microcatheter, 2.4F 130cm Straight, REF28MC24130ST, Rx Only, Non-pyrogenic Sterile if package is unopened or undamaged.
- Company
- Merit Medical Systems, Inc
- Recall Initiated
- September 26, 2014
- Posted
- October 31, 2014
- Terminated
- November 19, 2014
- Recall Number
- Z-0162-2015
- Quantity
- 56 units
- Firm Location
- South Jordan, UT
Reason for Recall
These microcatheters were packaged with a 2.8 F distal tip, rather than the labeled 2.4 F.
Distribution
Nationwide and to India. No govt/military/VA consignees.
Lot / Code Info
Catalog No: 28MC24130ST, Lot H665694, H669824, Exp 2017 and Catalog No: 28MC24150SN, Lot H665696, Exp 7/31/2014
Root Cause
Mixed-up of materials/components
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.