Recall Z-0746-2007 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Boston Scientific Corp
Vaxcel Implantable Vascular Access System - Plastic Standard Port With 9F Polyurethane Catheter, Catalog/REF No. 45-360, UPN/Material No. M001453600, Single Use Only, STERILE, EO, Boston Scientific MEDI-TECH (617) 972-4000/(800) 225--3238, 480 Pleasant Street, Watertown, MA 02472 --- The port is provided as a kit, with various single use, disposable items necessary for achieving vascular access a
| Date | Apr 14, 2007 (initiated Jun 13, 2006) |
| Status | Terminated |
| Reason | Mispackaging: some kits of peelable sheaths/dilators may contain a 10F sheath instead of a 9F sheath--(Recalling Firm was notified by their supplier B. Braun Medical of the error) |
| Root cause | Other |
| Action | Boston Scientific sent Urgent Medical Device Recall Notification- Immediate Action Required letters- (dated 6/13/06) to all 11 end users via Federal Express. The letters informed the end users that some of the peelable sheaths/dilators in the Vaxcel Implantable Vascular Access kits may incorrectly contain 10F sheaths instead of 9F sheaths which had been supplied by B. Braun Medical Inc. Improper sizing of the sheath for the catheter may result in difficulty /inability to insert the catheters. The letters instructed the end users to immediately remove the affected lots from inventory, segregate |
| Quantity | 5 |
| Distribution | NY, CA, MD, WA, TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K954258 | TRIMPORT IMPLANTABLE ACCESS SYSTEM (MODIFICATION) Gerard Medical Enterprises, Inc., May 24, 1996 |