Recall Z-0878-2010 ยท KRA Catheter, Continuous Flush
Merit Medical Systems, Inc.
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.
| Date | Mar 2, 2010 (initiated Jan 6, 2010) |
| Status | Terminated |
| Reason | Infusion catheters may become brittle and break during use. |
| Root cause | Storage |
| Action | 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. |
| Quantity | 25 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K974067 | FOUNTAIN INFUSION CATHETER AND OCCLUDING GUIDE WIRE Merit Medical Systems, Inc., Feb 27, 1998 |