Recall Z-0433-06 ยท DQY Catheter, Percutaneous
Boston Scientific Scimed
Mach 1 6F JR 3.5 Guide Catheter. Catalog No. 34356-685. Sterilized with ethylene oxide gas. Nonpyrogenic. Intended for one procedure use only. Manufacture: Boston Scientific Scimed, Inc., One Scimed Place, Maple Grove, MN USA 55311
| Date | Jan 24, 2006 (initiated May 24, 2004) |
| Status | Terminated |
| Reason | Some Mach 1 6F Coronary Guide Catheter could be mislabeled in that a few units labeled as Mach 1 6F Kimny Curve style, could contain a Mach 1 6F JR 3.5 curve style and a few units labeled as Mach 1 6F JR 3.5 curve style, could contain a Mach 1 6F Kimny curve style. |
| Root cause | Other |
| Action | A Recall Notice, dated 05/28/05, was sent to Risk Managers. The notice informed them of the issue and instructed them to discontinue use and segregate affected units. A Tracking/verification Form is requested to be returned. Arrangements will be made for returning affected product. |
| Quantity | 10 devices |
| Distribution | Within the US to GA, MS, NC ,TN. OUS to include: Canada, Hong Kong, Italy, Netherlands, Saudi Arabia, United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010874 | 6F MACH 1, MODEL 34356-XXX Boston Scientific Corp, Jun 21, 2001 |