—#118029

Product

Merit Medical PerfOrma Anglographic Catheter 5F Multipack Product Usage: Angiographic catheters are designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures.

FDA product code: DQO — Catheter, Intravascular, Diagnostic
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K943739
Affected lot / code info: Lot Numbers: 1662386, 1662390, 1662385, 1662387, 1662391

Why it was recalled

Merit Medical Systems is recalling various lots of Performa Cardiac Multipacks containing a JR4.0 catheter due to a slight variation in tip shape.

Root cause (FDA determination)

Process control

Action the firm took

Merit sent an Urgent Product Recall Notice letter dated May 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were asked to identify, quarantine, discontinue using products, and contact their sales representative to arrange product return and replacement or credit. For questions call 1-801-208-4468.

Recalling firm

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

Distribution

Distribution pattern: USA Nationwide Distribution.

Timeline

Recall initiated: 2013-05-02
Posted by FDA: 2013-05-25
Terminated: 2013-07-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #118029. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.