Recalls / —

—#175641

Product

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

FDA product code

KNW — Instrument, Biopsy

Device class

Class 2

Medical specialty

Gastroenterology, Urology

510(k) numbers

K171531

Affected lot / code info

Lot Number: 0001159474 Exp. Date: 2022-08-31 UDI: (01)10885403044564 + (10)0001159474(17)220831

Why it was recalled

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

Root cause (FDA determination)

Packaging process control

Action the firm took

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.

Recalling firm

Firm

Becton Dickinson & Company

Address

1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

Distribution pattern

CA, IL Foreign: Taiwan

Timeline

Recall initiated

2019-08-01

Terminated

2020-05-06

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #175641. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.