Recalls / —

—#70478

Product

Custom Kit, REF: K05-00843, Revision L, 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 F580867

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 #70478. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.