Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall see related information
Date Initiated by Firm January 22, 2003
Date Posted February 13, 2003
Recall Status1 Terminated 3 on March 26, 2003
Recall Number Z-0554-03
Recall Event ID 25427
510(K)Number K990072  
Product Classification Dilator, Catheter, Ureteral - Product Code EZN
Product Pursuit ureteral dilation balloon catheters, 6 mm x 4 cm. Order # PAB-050080-6-4.0
Code Information Lot 1049345
Recalling Firm/
Manufacturer		 Cook Urological, Inc.
1100 West Morgan
Spencer IN 47460
For Additional Information Contact
812-829-4891
Manufacturer Reason
for Recall		 Product is labeled sterile, but was not sterilized.
FDA Determined
Cause 2		 Other
Action Customers were notified by phone call and recall letter beginning on 1/22/03.
Quantity in Commerce 15
Distribution Alaska, Hawaii, Minnesota, Ohio, Tennessee and Ireland.
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 = EZN and Original Applicant = COOK UROLOGICAL, INC.
-
-