—#41869

Product

Merit Custom Procedure Kit

FDA product code: DQO — Catheter, Intravascular, Diagnostic
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K913682
Affected lot / code info: Part Number: K09-05248P. Lot Numbers: A304826, A314447, A316544, A322290, A325742, A336903, A345355.

Why it was recalled

Component of procedure kits may allow higher than desired amount of IV solution to be infused in to patient during pressure monitoring procedure.

Root cause (FDA determination)

Other

Action the firm took

Consignees were notified by letter on 9/2/2005.

Recalling firm

Firm: Merit Medical Systems, Inc
Address: 1600 West Merit Pkwy South, Jordan, Utah 84095-2416

Distribution

Distribution pattern: DC, MD, VA. Foreign distributiion to Netherlands and Switzerland. No government or military accounts.

Timeline

Recall initiated: 2005-09-02
Posted by FDA: 2005-10-21
Terminated: 2005-10-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #41869. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.