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U.S. Department of Health and Human Services

Class 2 Device Recall Cook Harrison fetal bladder stent

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  Class 2 Device Recall Cook Harrison fetal bladder stent see related information
Date Initiated by Firm March 01, 2006
Date Posted March 23, 2006
Recall Status1 Terminated 3 on July 01, 2008
Recall Number Z-0674-06
Recall Event ID 34671
Product Classification Stent, Ureteral - Product Code FAD
Product Cook Harrison fetal bladder stent set, sterile; REF J-HFBS-503540.
Code Information All units.
Recalling Firm/
Manufacturer		 Cook Urological, Inc.
1100 W Morgan St
Spencer IN 47460-9426
For Additional Information Contact Julie Ross
812-829-4891
Manufacturer Reason
for Recall		 Instructions for Use (IFU) booklet missing pages 5-12. Pages 5-8 in English; 9-12 in Danish, describe stent duration, patient preparation, assembly, implanting, follow-up and removal instructions. IFU, device description, indications, contraindications, warnings, precautions, patient counseling, clinical usage, clinical study data, adverse events. One patient booklet lacked pages 3-6, & 55-58.
FDA Determined
Cause 2		 Other
Action Consignees were notified via letter dated 3/1/06 that included one copy of the instructions. Consignees were asked to inform the firm of how many additional copies were needed for stocks on hand and instructed to make copies as needed until additional supplies are received.
Quantity in Commerce 1300
Distribution Nationwide, Australia, Canada, Caracas, Chile, Colombia, Hong Kong, India, Ireland, Israel, Malaysia, Mexico, New Zealand, Paraguay, Taiwan and Venezuela.
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.
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