Recall Z-0925-03 ยท FPA Set, Administration, Intravascular
Venetec Intl Inc
StatLock Tandem Microbore Catheter Extension Set with preattached Clearlink Valve 6'' LL. Model number 2N9205K.
| Date | Jun 12, 2003 (initiated May 12, 2003) |
| Status | Terminated |
| Reason | Set tubing disconnected from the male luer lock during use on patients. Misassembled. |
| Root cause | Other |
| Action | A recall letter was sent to the distributor who then sent thier own letters to the affected hospitals. Hospitals were reached on or about May 14, 2003 whereas the distributor was contacted by telephone and letter on or about May 12, 2003. It was verbally agreed that the distributor would subrecall the product. |
| Quantity | 3150 units |
| Distribution | One distributor sent the product to 6 hospitals in the states of CT, IN, PA, TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K980992 | IV ADMINISTRATION SETS WITH NEEDLELESS ACCESS DEVICES Venetec Intl., Inc., May 28, 1998 |