Vaxcel Implantable Vascular Access System - Titanium Mini-Port with PASV Valve and 8F Silicone Catheter, REF/Catalog No.

FDA device recall Z-0631-2007 · posted 2007-03-15 · Terminated

Recall details

Recalling firm

Boston Scientific Corp

Reason for recall

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.

Action taken

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 # on the outside of the shipping carton, and return the recalled product to Boston Scientific Corp. 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 user, and mailed or faxed back to Boston Scientific.

Root cause

Other

Status

Terminated

Product code

LJT

Quantity affected

Domestic - 42

Distribution

Nationwide

Date initiated

2006-09-27

Date posted

2007-03-15

Date terminated

2007-11-26

Location

Glens Falls, NY

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