Date Initiated by Firm |
January 02, 2007 |
Date Posted |
March 16, 2007 |
Recall Status1 |
Terminated 3 on December 05, 2007 |
Recall Number |
Z-0637-2007 |
Recall Event ID |
37102 |
510(K)Number |
K950118
|
Product Classification |
Catheter - Product Code FOZ
|
Product |
COOK Triple Lumen Central Venous Catheter Tray with Cook Spectrum¿ Glide¿ Antimicrobial Catheter with EZ--Pass¿ Hydrophilic Coating: Reorder Number C-UTLMY-701J-RSC-ABRM-HC-FST-A. |
Code Information |
Lots 1794998 and 1793611. |
Recalling Firm/ Manufacturer |
Cook, Inc. 750 Daniels Way Bloomington IN 47404-9120
|
For Additional Information Contact |
800-346-2626
|
Manufacturer Reason for Recall |
These catheters do not include the proximal sidehole as required by the specification.
|
FDA Determined Cause 2 |
Other |
Action |
Consignees were notified by phone on 1/2/07 and instructed to return the product. |
Quantity in Commerce |
100 |
Distribution |
Nationwide, including the states of Florida, Louisiana, Maine, Massachusetts, Minnesota, Missouri, New Jersey and North Carolina. |
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 = COOK, INC.
|