Mistique Infusion Catheter, MIC5-90-5-035, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to
FDA device recall Z-0872-2010 · posted 2010-03-02 · Terminated
Recall details
- Recalling firm
- Merit Medical Systems, Inc.
- Reason for recall
- Infusion catheters may become brittle and break during use.
- 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.
- Root cause
- Storage
- Status
- Terminated
- Product code
- KRA
- Quantity affected
- 5 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.
- Date initiated
- 2010-01-06
- Date posted
- 2010-03-02
- Date terminated
- 2010-09-13
- Location
- South Jordan, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FOUNTAIN INFUSION CATHETER AND OCCLUDING GUIDE WIRE (K974067) | Merit Medical Systems, Inc. | 1998-02-27 |