Recalls / —

—#122251

Product

Merit Medical Performa Angiographic Catheter 5F Multipack. Part numbers 7560-43 and 7560-G3.

FDA product code

DQO — Catheter, Intravascular, Diagnostic

Device class

Class 2

Medical specialty

Cardiovascular

510(k) numbers

K943739

Affected lot / code info

Part Number/Lot Number: 7560-43/I663860, 7560-43/I663861, 7560-G3/I664519 and 7560-G3/I666388.

Why it was recalled

4 lots of Performa Cardiac Multipacks contain a JR4.0 catheter with a slight variation in tip shape.

Root cause (FDA determination)

Process control

Action the firm took

Consignees were notified on 9/13/13 via Urgent Product Recall Notice, email, and product retrieval forms. Actions required of customers: 1. Please immediately determine if any of the devices are within your facility, quarantine them and discontinue use. 2. Ensure that all personnel to whom the devices were distributed are made aware of this field action. 3. Contact your Merit Sales Representative in order to arrange product return and replacement or credit. 4. If you have any questions concerning this communication, please don't hesitate to contact Guido Sandulli at 1-801-826-4046.

Recalling firm

Firm

Merit Medical Systems, Inc.

Address

1600 West Merit Parkway, South Jordan, Utah 84095

Distribution

Distribution pattern

US Distribution including the states of CO, VA, and MS.

Timeline

Recall initiated

2013-09-13

Posted by FDA

2013-10-22

Terminated

2014-01-03

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #122251. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.