Z-2411-2019Class II

8 G x 10 CM Jamshidi Crown Bone Marrow biopsy/Aspiration Needle with MAC Catalog Number: TMJ4008

Name: Z-2411-2019 8 G x 10 CM Jamshidi Crown Bone Marrow biopsy/Aspiration Needle with MAC Catalog Number: TMJ4008
Creator: Becton Dickinson & Company
Published: 2019-08-01
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2019-08-01 / Terminated / root cause: packaging

FDA source

Becton Dickinson & Company began a recall of 8 G x 10 CM Jamshidi Crown Bone Marrow biopsy/Aspiration Needle with MAC Catalog Number: TMJ4008 on 2019-08-01. FDA classified it as Class II and gives the reason as "Product Pouches may not be sealed properly and compromise the sterility of the device". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2411-2019
Classification: Class II
Status: Terminated
Initiated: 2019-08-01
Posted: 2019-08-28
Terminated: 2020-05-06
Recalling firm: Becton Dickinson & Co
Product: 8 G x 10 CM Jamshidi Crown Bone Marrow biopsy/Aspiration Needle with MAC Catalog Number: TMJ4008
Product code: KNW Instrument, Biopsy
Reason for recall: Product Pouches may not be sealed properly and compromise the sterility of the device
Root cause tag: packaging
FDA 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 in commerce: 700 units
Distribution: CA, IL Foreign: Taiwan
Product codes and lots: Lot Number: 0001159474 Exp. Date: 2022-08-31 UDI: (01)10885403044564 + (10)0001159474(17)220831

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2411-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2411-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-04	2019-08-27

Product code KNW

K171531Class IIJamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle, Jamshidi Evolve Bone Marrow Biopsy/Aspiration NeedleCare Fusion / cleared 2017-09-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)