—#70477

Product

Custom Kit, Custom Angiographic Kit, REF: K05-YS1032, Revision A, Sterile, Merit Medical Systems, Inc., South Jordan, Utah 84095.

FDA product code: DQO — Catheter, Intravascular, Diagnostic
Device class: Class 2
Medical specialty: Cardiovascular
Affected lot / code info: Lot Number F603790

Why it was recalled

Convenience kits may be non-sterile due to inadequate package sealing.

Root cause (FDA determination)

Process control

Action the firm took

Consignees were notified by letter (Urgent Product Recall) on 04/15/2008 and instructed to quarantine all affected kits for return to Merit. A Product Retrieval Form was included to be completed by the site representative. Please contact Greg Turner at 1-801-316-4998 or Jon Davis at 801-208-4497.

Recalling firm

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

Distribution

Distribution pattern: MO. Foreign distribution to Japan. No military or government distribution.

Timeline

Recall initiated: 2008-04-15
Posted by FDA: 2008-09-04
Terminated: 2008-09-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #70477. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.