FDA recall Z-2490-2020
Prodimed Plastimed Division · Class II · device
Product
Prodimed Combicath catheters for blind or fibrescope-guided protected distal bronchial sampling (PDBS)- COMBICATH PE 90 cm Product Code: 58229 19
Reason for recall
Lack of assurance of sterility
Distribution
Nationwide
Key facts
- Status
- Terminated
- Initiation date
- 2020-05-27
- Report date
- 2020-07-15
- Termination date
- 2021-03-29
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Le Plessis Bouchard, France
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2490-2020