FDA Device

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***''

Hazard

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.

What You Should Do

Remedy

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

Products

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, Th
Brand
Cordis Corporation
UPC
Lot numbers R0305581, R0305159, R0305284, R0305286, R0305155 and R0305104.

Units Affected

48 units