Recall Z-0631-2007 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Boston Scientific Corp
Vaxcel Implantable Vascular Access System - Titanium Mini-Port with PASV Valve and 8F Silicone Catheter, REF/Catalog No. 45-220, UPN/Material No. M001452200,
| Date | Mar 15, 2007 (initiated Sep 27, 2006) |
| Status | Terminated |
| Reason | Sterile barrier may have been compromised. Firm received one complaint which demonstrated that the inner and outer seals of the port tray packaging had been compromised. |
| Root cause | Other |
| Action | On 9/27/06, Boston Scientific Corp. sent Urgent Medical Device Recall - Immediate Action Required letters (dated 9/27/06) via Federal Express to the 84 end users (medical facilities). The letters informed the users of the recall of the products due to a compromised sterile barrier. The letters instructed the users to immediately remove the affected lots from inventory, segregate them, contact Boston Scientific at 1-800-862-1284 to obtain a Return Authorization (RGA) number, return the product in an appropriate shipping carton, place the label on the outside of the shipping box, write the RGA |
| Quantity | Domestic - 42 |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030083 | VAXCEL WITH PASV PORT Boston Scientific Corp, Jan 28, 2003 |