Recalls / —

—#30460

Product

UHF Cardiac Pigtail non-wirebraid, 7F, 110 cm, Angiographic Catheter, Sterile, Merit Medical.

FDA product code

DQO — Catheter, Intravascular, Diagnostic

Device class

Class 2

Medical specialty

Cardiovascular

510(k) numbers

K943739

Affected lot / code info

Catalog Number7779-10, Lots G270628, G283744, G260778.

Why it was recalled

Angiographic catheter tips may separate during use.

Root cause (FDA determination)

Other

Action the firm took

All 7 consignees were contacted by their sales representatives on 11/5-7/2003.

Recalling firm

Firm

Merit Medical Systems, Inc

Address

1600 Merit Pkwy South, Jordan, Utah 84095-2416

Distribution

Distribution pattern

FL, MI, NY, PA, TN, TX. No foreign, government, or military distribution.

Timeline

Recall initiated

2003-11-05

Posted by FDA

2003-11-27

Terminated

2003-12-01

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #30460. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.