Recall Z-0884-2010
Merit Medical Systems, Inc. · initiated January 6, 2010
Product
Mistique Infusion Catheter, MIC5-135-5-035, 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.
Codes / lots: Lot numbers: F523173, F727966, and F739396.
Reason for recall
Infusion catheters may become brittle and break during use.
FDA-determined 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.
Details
- Recall number
- Z-0884-2010
- Initiated
- January 6, 2010
- Posted by FDA
- March 2, 2010
- Terminated
- September 13, 2010
- Product code
- KRA – Catheter, Continuous Flush
- Quantity
- 19 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.
- Recalling firm
- Merit Medical Systems, Inc., South Jordan, UT
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0872-2010 | Mistique Infusion Catheter, MIC5-90-5-035, Sterile EO, Merit Medical Systems, Inc.…Infusion catheters may become brittle and break during use. | 01/06/2010Terminated |
| Z-0873-2010 | Mistique Infusion Catheter, MIC5-90-20-038, Sterile EO, Merit Medical Systems, Inc.…Infusion catheters may become brittle and break during use. | 01/06/2010Terminated |
| Z-0874-2010 | Mistique Infusion Catheter, MIC5-90-20-035, Sterile EO, Merit Medical Systems, Inc.…Infusion catheters may become brittle and break during use. | 01/06/2010Terminated |
| Z-0875-2010 | Mistique Infusion Catheter, MIC5-90-10-038, Sterile EO, Merit Medical Systems, Inc.…Infusion catheters may become brittle and break during use. | 01/06/2010Terminated |
| Z-0876-2010 | Mistique Infusion Catheter, MIC5-90-10-035, Sterile EO, Merit Medical Systems, Inc.…Infusion catheters may become brittle and break during use. | 01/06/2010Terminated |
| Z-0877-2010 | Mistique Infusion Catheter, MIC5-45-5-035, Sterile EO, Merit Medical Systems, Inc.…Infusion catheters may become brittle and break during use. | 01/06/2010Terminated |
| Z-0878-2010 | Mistique Infusion Catheter, MIC5-45-5-038, Sterile EO, Merit Medical Systems, Inc.…Infusion catheters may become brittle and break during use. | 01/06/2010Terminated |
| Z-0879-2010 | Mistique Infusion Catheter, MIC5-45-20-038, Sterile EO, Merit Medical Systems, Inc.…Infusion catheters may become brittle and break during use. | 01/06/2010Terminated |
| Z-0880-2010 | Mistique Infusion Catheter, MIC5-45-20-035, Sterile EO, Merit Medical Systems, Inc.…Infusion catheters may become brittle and break during use. | 01/06/2010Terminated |
| Z-0881-2010 | Mistique Infusion Catheter, MIC5-45-10-038, Sterile EO, Merit Medical Systems, Inc.…Infusion catheters may become brittle and break during use. | 01/06/2010Terminated |
| Z-0882-2010 | Mistique Infusion Catheter, MIC5-45-10-035, Sterile EO, Merit Medical Systems, Inc.…Infusion catheters may become brittle and break during use. | 01/06/2010Terminated |
| Z-0883-2010 | Mistique Infusion Catheter, MIC5-135-5-038, Sterile EO, Merit Medical Systems, Inc.…Infusion catheters may become brittle and break during use. | 01/06/2010Terminated |
| Z-0885-2010 | Mistique Infusion Catheter, MIC5-135-20-038, Sterile EO, Merit Medical Systems, Inc.…Infusion catheters may become brittle and break during use. | 01/06/2010Terminated |
| Z-0886-2010 | Mistique Infusion Catheter, MIC5-135-20-035, Sterile EO, Merit Medical Systems, Inc.…Infusion catheters may become brittle and break during use. | 01/06/2010Terminated |
| Z-0887-2010 | Mistique Infusion Catheter, MIC5-135-10-038, Sterile EO, Merit Medical Systems, Inc.…Infusion catheters may become brittle and break during use. | 01/06/2010Terminated |
| Z-0888-2010 | Mistique Infusion Catheter, MIC5-135-10-035, Sterile EO, Merit Medical Systems, Inc.…Infusion catheters may become brittle and break during use. | 01/06/2010Terminated |
| Z-0889-2010 | Mistique Infusion Catheter, K12-MIC13510, Sterile EO, Merit Medical Systems, Inc., South…Infusion catheters may become brittle and break during use. | 01/06/2010Terminated |
| Z-0890-2010 | Mistique Infusion Catheter, K12-MIC13505, Sterile EO, Merit Medical Systems, Inc., South…Infusion catheters may become brittle and break during use. | 01/06/2010Terminated |
| Z-0891-2010 | Mistique Infusion Catheter, K12-MIC09010, Sterile EO, Merit Medical Systems, Inc., South…Infusion catheters may become brittle and break during use. | 01/06/2010Terminated |
| Z-0892-2010 | Mistique Infusion Catheter, K12-MIC09005, Sterile EO, Merit Medical Systems, Inc., South…Infusion catheters may become brittle and break during use. | 01/06/2010Terminated |
| Z-0893-2010 | Mistique Infusion Catheter, K12-MIC04510, Sterile EO, Merit Medical Systems, Inc., South…Infusion catheters may become brittle and break during use. | 01/06/2010Terminated |
| Z-0894-2010 | Mistique Infusion Catheter, K12-MIC04505, Sterile EO, Merit Medical Systems, Inc., South…Infusion catheters may become brittle and break during use. | 01/06/2010Terminated |