Z-0746-2007

Vaxcel Implantable Vascular Access System - Plastic Standard Port With 9F Polyurethane Catheter, Catalog/REF...

Name: Z-0746-2007 Vaxcel Implantable Vascular Access System - Plastic Standard Port With 9F Polyurethane Catheter, Catalog/REF...
Creator: Boston Scientific Corp
Published: 2006-06-13
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2006-06-13 / Terminated / root cause: packaging

FDA source

Boston Scientific Corp began a recall of Vaxcel Implantable Vascular Access System - Plastic Standard Port With 9F Polyurethane Catheter, Catalog/REF No. 45-360, UPN/Material No. M001453600, Single... on 2006-06-13. The reason FDA records is "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)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0746-2007
Status: Terminated
Initiated: 2006-06-13
Posted: 2007-04-14
Terminated: 2007-04-23
Recalling firm: Boston Scientific Corporation
Product: 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 and implanting the port catheter. Each kit is provided in a plastic (PETG) tray with a heat-sealed tyvek lid. This inner tray is then placed in a second outer plastic (PETG) tray, along with the Directions for Use, and also sealed with a tyvek lid which is then labeled. The port kit is placed in a cardboard carton, with additional labels and sealed.
Product code: LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Reason for recall: 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 tag: packaging
FDA 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 the recalled product, contact Boston Scientific at 1-800-862-1284 to obtain a Return Authorization (RGA) number, pack the product in an appropriate shipping carton, affix the shipping label to the outside of the shipping carton, write the RGA number on the outside of the shipping carton, and to return the recalled product to Boston Scientific''s Distribution Center Attn: QA Returns, 500 Commander Shea Blvd., Quincy, MA 02171. Accompanying each letter was a Reply Verification Tracking Form to be completed by the end user and mailed or faxed to Boston Scientific even if the user did not have the recalled lots on hand.
Quantity in commerce: 5
Distribution: NY, CA, MD, WA, TN.
Product codes and lots: Lots 1109717 and 1120230

Product code LJT

K954258Class IITrimport Implantable Access System (Modification)Gerard Medical Enterprises, Inc. / cleared 1996-05-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)