Recall Z-2411-2019 ยท KNW Instrument, Biopsy
Becton Dickinson & Company
8 G x 10 CM Jamshidi Crown Bone Marrow biopsy/Aspiration Needle with MAC Catalog Number: TMJ4008
| Date | Aug 1, 2019 |
| Status | Terminated |
| Reason | Product Pouches may not be sealed properly and compromise the sterility of the device |
| Root cause | Packaging process control |
| Action | BD notified US consignees via FedEx August 1, 2019,and contacted via email. Sub recall requested and BD will notify customers. BD is requesting that customers destroy product at their location. The kit packer asked to return product. BD will mail additional communications to the kit customers. A business response form is included with the letter to assist direct consignees in responding to the field action. Questions contact BD Customer/Technical Support 800-638-8663 Monday Friday between 7:00am and 7:00pm (EST) in the United States. |
| Quantity | 700 units |
| Distribution | CA, IL Foreign: Taiwan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171531 | Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle, Jamshidi Evolve B Care Fusion, Sep 11, 2017 |