Date Initiated by Firm |
January 05, 2007 |
Date Posted |
January 25, 2007 |
Recall Status1 |
Terminated 3 on May 01, 2008 |
Recall Number |
Z-0377-2007 |
Recall Event ID |
37115 |
510(K)Number |
K043418
|
Product Classification |
endoscope - Product Code FED
|
Product |
Cook Flexor DL Dual Lumen Ureteral Access Sheath with AQ Coating, sterile, REF FUS-095013-DL. |
Code Information |
Lot U1546391. |
Recalling Firm/ Manufacturer |
Cook Urological, Inc. 1100 W Morgan St Spencer IN 47460-9426
|
For Additional Information Contact |
812-829-4891
|
Manufacturer Reason for Recall |
Lack of assurance of sterility, as the packages may not have been sealed.
|
FDA Determined Cause 2 |
Other |
Action |
Consignees were notified via recall letter dated 1/5/07 and requested to return the product. |
Quantity in Commerce |
4 |
Distribution |
Massachusetts, Maine, New Hampshire and Puerto Rico. |
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 = FED and Original Applicant = COOK UROLOGICAL, INC.
|