Device product
Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH PE 85 cm x 4.0 mm 58124 40US
Z-2488-2020
Product summary
- Event
- Event 85776
- Status
- Terminated
- Classification
- Class II
- Quantity
- 39800
- Official record key
device-enforcement:Z-2488-2020
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