Jamshidi recallZ-2411-2019 · Becton Dickinson & Company · initiated Aug 1, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Becton Dickinson & Company or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Product Pouches may not be sealed properly and compromise the sterility of the device
FDA root cause category: Packaging process control
What the company is doing
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.
Recall details
- Recall number
- Z-2411-2019
- Status
- Terminated
- Initiated by the company
- Aug 1, 2019
- Recalling firm
- Becton Dickinson & Company
- Quantity
- 700 units
- Product code
- KNW
- FDA submissions
- K171531
- Distribution
- CA, IL Foreign: Taiwan
Product description
8 G x 10 CM Jamshidi Crown Bone Marrow biopsy/Aspiration Needle with MAC Catalog Number: TMJ4008
Code information (models, lots, serial numbers)
Lot Number: 0001159474 Exp. Date: 2022-08-31 UDI: (01)10885403044564 + (10)0001159474(17)220831
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Jamshidi TJM4008Carefusion 2200, Inc · INSTRUMENT, BIOPSY2 recalls1 report
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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