—#87909

Product

Mistique Infusion Catheter, K12-MIC09005, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.

FDA product code: KRA — Catheter, Continuous Flush
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K974067
Affected lot / code info: Lot Numbers: F725685, F613221, F682088, F717755, F651484, F515919, F525522, F616416, F586945, F598771, F568275, F586078, F598764, F601954, F630041, F638412, F645779, and F758857.

Why it was recalled

Infusion catheters may become brittle and break during use.

Root cause (FDA determination)

Storage

Action the firm took

All affected sales reps were notified by phone and a Mistique Infusion Catheter - Product Recall letter on 01/06/2010 and instructed to contact their accounts, inform them of the recall situation, and complete the Recall Notification form with a site representative. Accounts were to immediately cease use of any affected units and to arrange for return to Merit. Recall actions are to be completed by Jan 22, 2010. Questions should be directed to Greg Turner at 801-316-4998 or Liz Pratt at 801-208-4828.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution -- USA, including states of AL, CA, IN, LA, MO, MS, NC, NY, OH, PA, SC, UT, and VA and countries of India, Japan, Poland, San Marino, and UK.

Timeline

Recall initiated: 2010-01-06
Posted by FDA: 2010-03-02
Terminated: 2010-09-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #87909. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.