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U.S. Department of Health and Human Services

Class 3 Device Recall Freezor cardiovascular catheter.

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  Class 3 Device Recall Freezor cardiovascular catheter. see related information
Date Initiated by Firm August 04, 2006
Date Posted August 29, 2006
Recall Status1 Terminated 3 on January 16, 2007
Recall Number Z-1452-06
Recall Event ID 36087
PMA Number P020045 
Product Classification cryoablation catheter - Product Code LPB
Product 7F Freezor Cardiac Cryoablation catheter, REF # 207F1. CryoCath Technologies Inc.
Code Information Reference # 207F1, Lot number 00418.
Recalling Firm/
CryoCath Technologies Inc.
16771 Chemin Ste-Marie
Kirkland Canada
For Additional Information Contact Flor del Pilar Arana
514-694-1212 Ext. 358
Manufacturer Reason
for Recall
Outer cartons of catheters were mislabeled with two different reference numbers. The front of the package showed the correct reference number; 207F1, however the section on the top of the box incorrectly referenced 207F3. All inside labels (inside the box and affixed on device pouches) showed the correct reference number, 207F1.
FDA Determined
Cause 2
Action Consignees were notified by letter on 08/04/2006.
Quantity in Commerce 34 units
Distribution Nationwide, including AZ, CA, CO, CT, DE, FL, GA, KY, MD, MI, NE, NY, OH, PA, TX.
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.
PMA Database PMAs with Product Code = LPB and Original Applicant = Medtronic CryoCath LP