Device product
Bone Marrow Aspiration Needle 15G x 2.688 MAX, Part Number DBMNI1501; Bone Marrow Aspiration Needle 15G x 4 MAX, Part Number DBMNI1504; Bone Marrow Aspiration Needle 16G x 2.688 MAX, Part Number DBMNI1601
Z-2188-2015
Product summary
- Event
- Event 71533
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6390 units
- Official record key
device-enforcement:Z-2188-2015
Official wording
Reason: Potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray.
Code information: Lot Numbers: 11088595, 11089104, 11089369, 11089370, 11094673, 11094679, 11095843, 11096115, 11098022, 11098023, 11098643, 11098707
Distribution pattern: US
Derived failure modes
-
Sterility assurance
package of the blister that may compromise the sterility