|
Class 2 Device Recall |
|
Date Initiated by Firm |
February 10, 2004 |
Date Posted |
July 20, 2004 |
Recall Status1 |
Terminated 3 on October 25, 2005 |
Recall Number |
Z-0732-04 |
Recall Event ID |
28398 |
510(K)Number |
K030083
|
Product Classification |
Port & Catheter, Implanted, Subcutaneous, Intravascular - Product Code LJT
|
Product |
Vaxcel Port with PASV Valve, 8 Fr polyurethane catheter, STD Titanium Port, Implantable Port System, Model # M001453620, Catalog #45-362 |
Code Information |
866762, 885272, 887739, 889302, 889704, 892898, 896675, 903724, 904485 |
Recalling Firm/ Manufacturer |
Boston Scientific Corporation 1 Boston Scientific Pl Natick MA 01760-1536
|
For Additional Information Contact |
Nancy Cutino 508-652-5066
|
Manufacturer Reason for Recall |
Reports of catheter separation/fracture after implantation resulting in distal migration of the catheter.
|
FDA Determined Cause 2 |
Other |
Action |
Letters dated 2/9/04 with instructions to return current inventory . Also included is information concerning implanted ports. |
Quantity in Commerce |
364 units |
Distribution |
Shipments were nationwide to 158 medical facilities nationwide. |
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 = LJT and Original Applicant = BOSTON SCIENTIFIC CORP.
|
|
|
|