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Terminated

Product 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***''

FDA Recall Z-1556-05 · Posted 2005-09-21

Recalling FirmCordis Corporation
Recall StatusTerminated
Product CodeLIT
Date Initiated2005-05-11
Date Terminated2008-11-20
Product Quantity48 units

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.

Firm Action

Recalled by letter and Cordis Sales Representatives interfacing directly with US consignees.

Root Cause

Other

Distribution Pattern

Distributed to 35 consignees throughout the US and other consignees in 11 countries worldwide.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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