Date Initiated by Firm |
October 28, 2005 |
Date Posted |
January 06, 2006 |
Recall Status1 |
Terminated 3 on February 15, 2007 |
Recall Number |
Z-0340-06 |
Recall Event ID |
33858 |
510(K)Number |
K954258
|
Product Classification |
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days - Product Code LJS
|
Product |
Vaxcel Implantable Vascular Access System - Titanium Mini Port with 7F Polyurethane Catheter. Boston Scientific Catalog # 45-305, M001453050. Firm on label: Boston Scientific/Medi-Tech, Watertown, MA 02472 |
Code Information |
1007398, 1017115, 1018449 |
Recalling Firm/ Manufacturer |
Boston Scientific Corporation 1 Boston Scientific Pl Natick MA 01760-1536
|
For Additional Information Contact |
Cindy Finney 508-683-4678
|
Manufacturer Reason for Recall |
Device kits contain B. Braun Locking Tearaway Introducer Systems labeled as 7Fr but may contain 8 Fr sheaths.
|
FDA Determined Cause 2 |
Other |
Action |
Boston Scientific letter dated 10/28/2005 sent via Federal Express. Customers (hospitals) instructed to remove and return product. |
Quantity in Commerce |
300 units |
Distribution |
DOMESTIC: Nationwide distribution. FOREIGN: Spain, France, Italy, Great Britain, Sweden, Jordan |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = LJS and Original Applicant = GERARD MEDICAL ENTERPRISES, INC.
|