FDA Medical Device Recalls (openFDA)
Becton Dickinson & Company: 8 G x 10 CM Jamshidi Crown Bone Marrow biopsy/Aspiration Needle with MAC Catalog Number: TMJ4008
- Recall number
- Z-2411-2019
- Recalling firm
- Becton Dickinson & Company
- Product
- 8 G x 10 CM Jamshidi Crown Bone Marrow biopsy/Aspiration Needle with MAC Catalog Number: TMJ4008
- Status
- Terminated
- Initiated
- 2019-08-01
- Posted
- not on file
- Terminated
- 2020-05-06
- 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
- Lot, serial or model codes
- Lot Number: 0001159474 Exp. Date: 2022-08-31 UDI: (01)10885403044564 + (10)0001159474(17)220831
- 510(k) numbers
- K171531
- PMA numbers
- not on file
- Product code
- KNW
- Firm FEI
- 2243072
- Firm city
- Franklin Lakes
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28