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U.S. Department of Health and Human Services

Class 2 Device Recall Cook Flexor DL

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  Class 2 Device Recall Cook Flexor DL see related information
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/
Cook Urological, Inc.
1100 W Morgan St
Spencer IN 47460-9426
For Additional Information Contact
Manufacturer Reason
for Recall
Lack of assurance of sterility, as the packages may not have been sealed.
FDA Determined
Cause 2
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.