Device product
T-Lok Bone Marrow Biopsy Needle 8G x 4 Ext Can, Part Number DBMNJ0804TL; T-Lok Bone Marrow Biopsy Needle 11G x 4 Ext Can, Part Number DBMNJ1104TL; Bone Marrow Biopsy Needle 13G x 4, Part Number DBMNJ1304
Z-2189-2015
Product summary
- Event
- Event 71533
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10290 units
- Official record key
device-enforcement:Z-2189-2015
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: 11088295, 11088596, 11088597, 11089105, 11089366, 11094182, 11094681, 11094912, 11095381, 11095844, 11095845, 11095951, 11096558, 11097278, 11097504, 11098024, 11098647, 11099173
Distribution pattern: US
Derived failure modes
-
Sterility assurance
package of the blister that may compromise the sterility