—#91473

Product

Vessel Sizing Angiographic Catheter, REF 7602-2M65, 5F PIG-VSC-2B, UHF Pigtail, Performa, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. 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: K000659
Affected lot / code info: Lot Number: G775032

Why it was recalled

Marker bands on angiographic catheters may not be properly attached, allowing movement of the bands.

Root cause (FDA determination)

Process control

Action the firm took

Merit Medical Systems, Inc. began notifying sales representatives beginning May 5, 2010 via phone and instructed to contact all of their affected accounts. All affected product was to be returned to the firm. For further information, contact Merit Medical at 1-713-757-5067 or 1-801-208-4468.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution -- GA, IL, MO, NY, PA and WI.

Timeline

Recall initiated: 2010-05-05
Posted by FDA: 2010-05-28
Terminated: 2010-06-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #91473. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.