Recall Z-1618-2008 ยท DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Boston Scientific Corp
Boston Scientific SteeroCath-Dx Diagnostic Catheter, Manufactured by Boston Scientific Corporation, San Jose, CA - Cardiac Catheter
| Date | Aug 30, 2008 (initiated Feb 14, 2008) |
| Status | Terminated |
| Reason | Package sterile barrier may be breached, compromising sterility. |
| Root cause | Nonconforming Material/Component |
| Action | Recall initiated on Feb. 14, 2008, via Urgent Medical Device Recall notification being sent to consignees, along with a reply verification tracking form. If you have questions or need a copy of the recall notification, contact Deborah J. Springer at 1-408-935-4944 or springed@bsci.com. |
| Quantity | 827 units total |
| Distribution | Worldwide Distribution --- including USA and countries of Saudi Arabia, Spain, Italy, Israel, Denmark, Canada and Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.