Recall Z-0642-2007 ยท DQX Wire, Guide, Catheter
Boston Scientific
Boston Scientific Medi-Tech(R) Katzen (TM) Infusion Wire, for the infusion of therapeutic agents (i.e. heparin, saline, thrombolytic agents, etc.) in the peripheral vasculature. The wire allows for the delivery of agents in either a 'pulse-spray' or 'slow weep' technique. Order No. REF: 46-193 (M001461930).
| Date | Mar 21, 2007 (initiated Dec 12, 2006) |
| Status | Terminated |
| Reason | Boston Scientific is voluntarily recalling one lot/batch of Katzen Infusion Wires because they have identified that the label on the carton may indicate a different length device than what is actually in the carton. The affected batch was manufactured using the Katzen Core Assembly of 146 cm, instead of a 177cm assembly. |
| Root cause | Other |
| Action | An Urgent Medical Device Recall letter, dated December 12, 2006 was sent to affected hospitals Risk Manager beginning 12/12/2006. The letter describes the issue and product affected, requests that further distribution or use of any remaining product cease immediately, and provides information for returning product to Boston Scientific Replacement product will be issued for all recalled product returned from affected facilities. A Reply Verification Tracking Form is requested to be completed and returned to Boston Scientific by Wednesday, December 27, 2006. |
| Quantity | 10 units |
| Distribution | US only to: FL, GA, IN, NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K883880 | KATZEN THROMBOLYSIS GUIDEWIRE Medi-Tech, Inc., Apr 6, 1989 |