—#78609

Product

Custom Angiographic Kit, K09-MS3084, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. Intended for fluid management convenience.

FDA product code: OEZ — Cardiovascular Procedure Kit
Device class: Class 2
Medical specialty: Cardiovascular
Affected lot / code info: Lot numbers: F581652, F591227, F606011, F612723, F639875, F643160, F650472, F667884.

Why it was recalled

A manufacturing defect may prevent adequate sterilization of the entire device.

Root cause (FDA determination)

Process control

Action the firm took

Applicable Merit sales representatives and distributors were notified by phone and letter beginning January 29, 2009 and instructed to immediately contact all affected consignees. Consignees were to immediately quarantine any remaining product and arrange for return to the firm. For further information, contact Merit Medical Systems, Inc. at 1-800-356-3748 extensions 4929 or 4998.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution -- United States ( PA and TX) and Japan.

Timeline

Recall initiated: 2009-01-29
Posted by FDA: 2010-01-29
Terminated: 2011-06-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #78609. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.