Recall Z-1513-05 ยท KOB Catheter, Suprapubic (And Accessories)
Boston Scientific Corporation
Implantable Chest Ports With PASV Valve Technology -Single Lumen - PASV Port/6.6/SL/T/PA Catalog Number: PRTA66P
| Date | Sep 2, 2005 (initiated Jul 22, 2005) |
| Status | Terminated |
| Reason | The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use. |
| Root cause | Other |
| Action | Boston Scientific intiated the recall on 7/22/05 to direct accounts and to distributors on 7/ 27 /05. Distributors are requested to conduct sub recalls to the medical facility level. A revised letter dated 8/2/05 was sent to 18 US accounts for one lot (#1020895) omitted in the letter of 7/22/05. |
| Distribution | Nationwide VA Hopsitals Foreign: Canada, Africa, Japan, Israel, Japan, Nertherlands, Venezula |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K991897 | CATHETER INNOVATIONS IMPLANTABLE PORT Catheter Innovations, Inc., Oct 21, 1999 |