Device product
8 G x 10 CM Jamshidi Crown Bone Marrow biopsy/Aspiration Needle with MAC Catalog Number: TMJ4008
Z-2411-2019
Product summary
- Event
- Event 83537
- Status
- Terminated
- Classification
- Class II
- Quantity
- 700 units
- Official record key
device-enforcement:Z-2411-2019
Official wording
Reason: Product Pouches may not be sealed properly and compromise the sterility of the device
Code information: Lot Number: 0001159474 Exp. Date: 2022-08-31 UDI: (01)10885403044564 + (10)0001159474(17)220831
Distribution pattern: CA, IL Foreign: Taiwan
Derived failure modes
-
Sterility assurance
Pouches may not be sealed properly and compromise the sterility