Recall Z-1164-2014 ยท DQY Catheter, Percutaneous
Boston Scientific Corporation
Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 38969-664.
| Date | Mar 10, 2014 (initiated Mar 3, 2014) |
| Status | Terminated |
| Reason | The sterile pouch of the devices from this lot may not be completely sealed and sterility may be compromised. The most common adverse health consequence expected from an unsealed pouch is a transient bacteremia, which may require antibiotic therapy. |
| Root cause | Packaging |
| Action | Consignees were sent a Boston Scientific "Urgent Medical Device Recall Removal " letter dated March 3, 2014. The letter described the problem and the product involved in the recall. The letter advised consignees to return the affected product and to complete and return the Account Reply Verification Tracking Form. The local Sales Representative can answer any questions that you may have regarding this Recall Removal. |
| Quantity | 7 |
| Distribution | TX and Russia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033441 | BOSTON SCIENTIFIC 6F RUNWAY GUIDE CATHETER Boston Scientific Corp, Nov 21, 2003 |