Recall Z-0104-2008 ยท DQY Catheter, Percutaneous
Boston Scientific
Boston Scientific mach 1 Guide Catheter, VL3.5 SH Voda Left 3.5, REF 34358-78, UPN H74934358780, Sterile EO, Made in Mexico Avenida Norske Edicficio G1, Local B y H Parque Industrial La Mesa, Fracc. Rubio La Mesa, Tijuana, B.C. Mexico C.P. 22550
| Date | Oct 27, 2007 (initiated Sep 11, 2007) |
| Status | Terminated |
| Reason | Missing holes: Catheters are missing the catheter's side holes. |
| Root cause | Process control |
| Action | A voice mail was left to affected members of the domestic sales force on September 11, 2007 and an interoffice memo with the recall implementation instructions was also sent to the Sales Force. An Urgent Voluntary Medical Device Recall letter dated September 11, 2007, was sent to affected consignees describing the problem and products affected. The letter included the customer steps for recall, a Reply Verification Tracking Form and a return shipping label. |
| Quantity | 7 |
| Distribution | Worldwide: NY, PA, and Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020028 | 6F MACH1/34356-XXX; 5F MACH1/35845-XXX; 7F MACH1/34357-XXX; 8F MACH1/34358-XXX Boston Scientific, Jan 22, 2002 |