Prodimed Plastimed Division

FDA Regulatory Profile

Summary

Total Recalls
6
510(k) Clearances
0
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2492-2020Class IIProdimed Combicath Paediatric catheters for blind protected distal bronchial sampling-" COMBICATH PEMay 27, 2020
Z-2491-2020Class IIProdimed Combicath Paediatric catheters for blind protected distal bronchial sampling- COMBICATH 35May 27, 2020
Z-2489-2020Class IIProdimed Combicath catheters for blind or fibrescope-guided protected distal bronchial sampling (PDBMay 27, 2020
Z-2488-2020Class IIProdimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH PE 85 cm x 4.0 mm 5812May 27, 2020
Z-2487-2020Class IIProdimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH PE 60 cm x 2.7 mm ProdMay 27, 2020
Z-2490-2020Class IIProdimed Combicath catheters for blind or fibrescope-guided protected distal bronchial sampling (PDBMay 27, 2020