—#40382

Product

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 product code: LIT — Catheter, Angioplasty, Peripheral, Transluminal
Device class: Class 2
Medical specialty: Cardiovascular
Affected lot / code info: Lot numbers R0305581, R0305159, R0305284, R0305286, R0305155 and R0305104.

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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

Recalling firm

Firm: Cordis Corporation
Address: 14201 NW 60th Ave, Miami Lakes, Florida 33014-2802

Distribution

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

Timeline

Recall initiated: 2005-05-11
Posted by FDA: 2005-09-21
Terminated: 2008-11-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #40382. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.