Product is a Powerflex P3 Dialation Catheter. Product is labeled in part: ''***POWERFLEX P3***Cordis***a Johnson and Joh
FDA device recall Z-1556-05 · posted 2005-09-21 · Terminated
Recall details
- Recalling firm
- Cordis Corporation
- 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.
- Action taken
- Recalled by letter and Cordis Sales Representatives interfacing directly with US consignees.
- Root cause
- Other
- Status
- Terminated
- Product code
- LIT
- Quantity affected
- 48 units
- Distribution
- Distributed to 35 consignees throughout the US and other consignees in 11 countries worldwide.
- Date initiated
- 2005-05-11
- Date posted
- 2005-09-21
- Date terminated
- 2008-11-20
- Location
- Miami Lakes, FL
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