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Class 2 Device Recall |
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Date Initiated by Firm |
January 22, 2003 |
Date Posted |
February 13, 2003 |
Recall Status1 |
Terminated 3 on March 26, 2003 |
Recall Number |
Z-0555-03 |
Recall Event ID |
25427 |
510(K)Number |
K990072
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Product Classification |
Dilator, Catheter, Ureteral - Product Code EZN
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Product |
Pursuit ureteral dilation balloon catheters, 6 mm x 8 cm. Order # PAB-050080-6-8.0 |
Code Information |
Lot 1050160 |
Recalling Firm/ Manufacturer |
Cook Urological, Inc. 1100 West Morgan Spencer IN 47460
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For Additional Information Contact |
812-829-4891
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Manufacturer Reason for Recall |
Product is labeled sterile, but was not sterilized.
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FDA Determined Cause 2 |
Other |
Action |
Customers were notified by phone call and recall letter beginning on 1/22/03. |
Quantity in Commerce |
9 |
Distribution |
Alaska, Hawaii, Minnesota, Ohio, Tennessee and Ireland. |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = EZN and Original Applicant = COOK UROLOGICAL, INC.
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