FDA recall Z-1477-2020
Cordis Corporation · Class II · device
Product
Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S
Reason for recall
Cordis is recalling one (1) lot of POWERFLEX P3 PTA Dilatation Catheter due to the potential for body/shaft voids in the proximal seal area.
Distribution
US and UK
Key facts
- Status
- Terminated
- Initiation date
- 2020-01-08
- Report date
- 2020-03-18
- Termination date
- 2023-01-13
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Miami Lakes, FL, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1477-2020