Mistique Infusion Catheter, MIC5-45-5-038, 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.
- Company
- Merit Medical Systems, Inc
- Recall Initiated
- January 6, 2010
- Posted
- March 2, 2010
- Terminated
- September 13, 2010
- Recall Number
- Z-0878-2010
- Quantity
- 25 units
- Firm Location
- South Jordan, UT
Reason for Recall
Infusion catheters may become brittle and break during use.
Distribution
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.
Lot / Code Info
Lot Numbers: F694689, F683489, F757981, F697877, and F683488.
Root Cause
Storage
Action Taken
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.