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Terminated

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

FDA Recall Z-2411-2019 · Posted None

Recalling FirmBecton Dickinson & Company
Recall StatusTerminated
Product CodeKNW
Date Initiated2019-08-01
Date Terminated2020-05-06
Product Quantity700 units

Reason for Recall

Product Pouches may not be sealed properly and compromise the sterility of the device

Firm 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.

Root Cause

Packaging process control

Distribution Pattern

CA, IL Foreign: Taiwan

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K171531Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle, Jamshidi Evolve Bone Marrow Biopsy/Aspiration NeedleCare Fusion · 2017-09-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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