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Class 3 Device Recall Freezor cardiovascular catheter. |
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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
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Product |
7F Freezor Cardiac Cryoablation catheter, REF # 207F1. CryoCath Technologies Inc. |
Code Information |
Reference # 207F1, Lot number 00418. |
Recalling Firm/ Manufacturer |
CryoCath Technologies Inc. 16771 Chemin Ste-Marie Kirkland Canada
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For Additional Information Contact |
Flor del Pilar Arana 514-694-1212 Ext. 358
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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.
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FDA Determined Cause 2 |
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
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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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PMA Database |
PMAs with Product Code = LPB and Original Applicant = Medtronic CryoCath LP
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