Date Initiated by Firm |
November 22, 2004 |
Date Posted |
January 20, 2005 |
Recall Status1 |
Terminated 3 on December 16, 2005 |
Recall Number |
Z-0407-05 |
Recall Event ID |
30572 |
510(K)Number |
K021704
|
Product Classification |
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days - Product Code LJS
|
Product |
VAXCEL PASV Peripherally Inserted Central Catheter, 3F, single lumen: CUSTOM KIT - GENESIS MEDICAL CENTER EAST, Catalog #60M120521, UPN # M00160M1205210; Firm on label: Boston Scientific Corp, NAMIC Technology Center, 10 Glens Falls Technical Park, Glens Falls, NY . DEVICE DESCRIPTION: A radiopaque, polyurethane catheter with a hub/suture wing, polyurethane extension leg(s) and luer locking adapter(s). A peel away sheath introducer allows for percutaneous insertion of the catheter. The hub/suture wing promotes fixation of the catheter hub to the patient''s skin. |
Code Information |
898658; 898990; 901923; 921920; 931621; 933875; 938673; 939255; 942560; 960665; 961989; 970713; 975113; 982649; |
Recalling Firm/ Manufacturer |
Boston Scientific Corporation 1 Boston Scientific Pl Natick MA 01760-1536
|
For Additional Information Contact |
Marie Peters 508-652-5875
|
Manufacturer Reason for Recall |
Catheter separation immediately distal to the nose of the suture wing.
|
FDA Determined Cause 2 |
Other |
Action |
Letters dated 11/22/2004 issued via Certified Mail. Customers instructed to return units in inventory. Patients with implanted units are to be evaluated. |
Quantity in Commerce |
179 kits |
Distribution |
75 hospitals and medical centers throughout the U.S. One foreign consignee, a hospital in New Brunswick, Canada. |
Total Product Life Cycle |
TPLC Device Report
|
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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 = CATHETER INNOVATIONS, INC.
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