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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmMay 11, 2005
Date PostedSeptember 21, 2005
Recall Status1 Terminated 3 on November 20, 2008
Recall NumberZ-1556-05
Recall Event ID 32576
Product Classification Catheter, Angioplasty, Peripheral, Transluminal - Product Code LIT
ProductProduct is a Powerflex P3 Dialation Catheter. Product is labeled in part: ''***POWERFLEX P3***Cordis***a Johnson and Johnson company***ENDOVASCULAR***STERILE EO***Cordis Europa N.V., 9301 LJ Roden, The Netherlands***''
Code Information Lot numbers R0305581, R0305159, R0305284, R0305286, R0305155 and R0305104.
FEI Number 1016427
Recalling Firm/
Manufacturer		 Cordis Corporation
14201 NW 60th Ave
Miami Lakes FL 33014-2802
Manufacturer Reason
for Recall		During competitive product testing, wire movement difficulties were observed in Powerflex P3 units. Due to the possibility of user inconvenience, Cordis is recalling the six affected lots of Powerflex P3. There is no patient impact.
FDA Determined
Cause 2		Other
ActionRecalled by letter and Cordis Sales Representatives interfacing directly with US consignees.
Quantity in Commerce48 units
DistributionDistributed to 35 consignees throughout the US and other consignees in 11 countries worldwide.
Total Product Life CycleTPLC 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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