Date Initiated by Firm |
May 22, 2006 |
Date Posted |
June 17, 2006 |
Recall Status1 |
Terminated 3 on December 12, 2007 |
Recall Number |
Z-1148-06 |
Recall Event ID |
35491 |
510(K)Number |
K902135
|
Product Classification |
venous access system - Product Code FOZ
|
Product |
Auto Suture-ChemoSite Low Profile -implantable low profile Venous Access System with printed polyurethane catheter and 9 French Introducer Kit Catalog Number: 120021 |
Code Information |
Lot Numbers: N5M40, N6B01 |
Recalling Firm/ Manufacturer |
United States Surgical 195 McDermott Rd North Haven CT 06473-3665
|
For Additional Information Contact |
Terrence Callahan 203-492-6273
|
Manufacturer Reason for Recall |
The 9F device may contain a 10 F sheath instead of the 9F
|
FDA Determined Cause 2 |
Other |
Action |
United States Surgical notified accounts by letter dated 5/22/06, requesting return of inventory. Distributors were requested to provide customer list to USS for contacting customers. |
Quantity in Commerce |
63 UNITS |
Distribution |
Nationwide and International
Australia, Brazil, Panama City, Singapore, Chile, France, Germany, Israel, Argentina, Quebec |
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 = FOZ and Original Applicant = DEVICE LABS, INC.
|