Date Initiated by Firm |
June 30, 2005 |
Date Posted |
August 06, 2005 |
Recall Status1 |
Terminated 3 on September 14, 2010 |
Recall Number |
Z-1092-05 |
Recall Event ID |
32569 |
510(K)Number |
K902135
|
Product Classification |
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days - Product Code LJS
|
Product |
ChemoSite Low Profile, Implantable Low Profile Mini Catheter Venous Access System with printed Polyurethane Catheter and 9 French Introducer Kit Catalog Number: 120021 |
Code Information |
Lot Numbers: N4G435 N4J328 N4K344 N5A181 |
Recalling Firm/ Manufacturer |
United States Surgical Corporation 195 Mcdermott Rd North Haven CT 06473-3665
|
For Additional Information Contact |
Lori Seferian 203-492-8167
|
Manufacturer Reason for Recall |
The peel away introducer sheath may have cracked hubs/handles and /or improper peeling of the sheath during use
|
FDA Determined Cause 2 |
Other |
Action |
United States Surgical notified customers by letter dated June 30, 2005 requesting return of the recalled product. |
Quantity in Commerce |
527 units |
Distribution |
Nationwide
Foreign: Australia, Canada, Germany,Israel, Uruguay, Chile, |
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 = DEVICE LABS, INC.
|