Class 3 Device Recall Freezor cardiovascular catheter.

• Date Initiated by Firm: August 04, 2006
• Date Posted: August 29, 2006
• Recall Status: Terminated 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.
• FEI Number: 3002648230
• Recalling Firm/ Manufacturer: 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: Other
• 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