Device product
Prodimed Combicath catheters for blind or fibrescope-guided protected distal bronchial sampling (PDBS)- COMBICATH PE 90 cm Product Code: 58229 19
Z-2490-2020
Product summary
- Event
- Event 85776
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1460
- Official record key
device-enforcement:Z-2490-2020
Official wording
Reason: Lack of assurance of sterility
Code information: All lots within expiry
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility