FDA Enforcement
Class II
Terminated
8 G x 10 CM Jamshidi Crown Bone Marrow biopsy/Aspiration Needle with MAC Catalog Number: TMJ4008
Recall: Z-2411-2019
·
Reported September 4, 2019
Enforcement
- Recall Number
- Z-2411-2019
- Event ID
- 83537
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Becton Dickinson & Company
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 4, 2019
- Initiation Date
- August 1, 2019
- Classification Date
- August 27, 2019
- Termination Date
- May 6, 2020
- Address
- 1 Becton Dr, N/A, Franklin Lakes, NJ, 07417-1815, United States
Description
8 G x 10 CM Jamshidi Crown Bone Marrow biopsy/Aspiration Needle with MAC Catalog Number: TMJ4008
Reason
Product Pouches may not be sealed properly and compromise the sterility of the device
Code Info
Lot Number: 0001159474 Exp. Date: 2022-08-31 UDI: (01)10885403044564 + (10)0001159474(17)220831
Distribution
CA, IL Foreign: Taiwan
Quantity
700 units