FDA recall Z-2488-2020
Prodimed Plastimed Division · Class II · device
Product
Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH PE 85 cm x 4.0 mm 58124 40US
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-2488-2020