Devices

Product is a Powerflex P3 Dialation Catheter. Product is labeled in part: ''POWERFLEX P3Cordisa Johnson and Johnson companyENDOVASCULARSTERILE EOCordis Europa N.V., 9301 LJ Roden, The Netherlands***''

Model / Serial
Lot numbers R0305581, R0305159, R0305284, R0305286, R0305155 and R0305104.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Distributed to 35 consignees throughout the US and other consignees in 11 countries worldwide.
Product Description
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***''
Manufacturer
Cordis Corporation
1 Event
- Recall of 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***''

Manufacturer

Cordis Corporation

Manufacturer Address
Cordis Corporation, 14201 NW 60th Ave, Miami Lakes FL 33014-2802
Manufacturer Parent Company (2017)
Cardinal Health
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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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***''

Manufacturer

Cordis Corporation

Product is a Powerflex P3 Dialation Catheter. Product is labeled in part: ''POWERFLEX P3Cordisa Johnson and Johnson companyENDOVASCULARSTERILE EOCordis Europa N.V., 9301 LJ Roden, The Netherlands***''