Recall Z-0510-2010 ยท DQO Catheter, Intravascular, Diagnostic
Merit Medical Systems, Inc.
Merit Medical Systems, Inc. Connection Tube label reading in part: CONNECTING TUBE 12" STERILE K10-04129, CATALOG NUMBER K10-04129 Connection tubing can be used with any drainage catheter and drainage bag
| Date | Dec 14, 2009 (initiated Sep 29, 2009) |
| Status | Terminated |
| Reason | Potential sterility breach caused by excessive shipment damage. |
| Root cause | Other |
| Action | Merit Medical Customers were contacted directly by phone and letter on 9/29/09. Customers were instructed to identify and quarantine all unused affected product. Further information was available at 801-208-4365. |
| Quantity | 1 connection tube |
| Distribution | US (AL, LA, MO, KY, TN, GA). No military, government or foreign distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K913682 | MERIT CUSTOM KIT Merit Medical Systems, Inc., Nov 15, 1991 |