Recall Z-2411-2019— Becton Dickinson & Company

Name: FDA recall Z-2411-2019
Creator: U.S. Food and Drug Administration
Published: 2019-08-01

Class II · Terminated

Class II FDA medical device recall by Becton Dickinson & Company, initiated 2019-08-01, terminated 2020-05-06. It names one FDA 510(k) clearance: K171531. Product: 8 G x 10 CM Jamshidi Crown Bone Marrow biopsy/Aspiration Needle with MAC Catalog Number: TMJ4008. Reason: Product Pouches may not be sealed properly and compromise the sterility of the device.

Recalling firm: Becton Dickinson & Company
Classification: Class II
Status: Terminated
Initiated: 2019-08-01
Terminated: 2020-05-06
Firm location: Franklin Lakes, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K171531 — Jamshidi 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

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.