Device product
Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH PE 60 cm x 2.7 mm Product Code: 58216 27US
Z-2487-2020
Product summary
- Event
- Event 85776
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7220
- Official record key
device-enforcement:Z-2487-2020
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