Bard Peripheral Vascular Inc recalls Jamshidi Bone Marrow Biopsy/Aspiration Needle, with Luer Lock Adapter 11GX4 ASP, Sterile - Product Code: DJ4011X - Prod…

Recall date

March 17, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1689-2020

FDA classification

Class II

Brand / firm

Bard Peripheral Vascular Inc

Sold / distributed

Worldwide distribution - US Nationwide distribution in the states of FL, IL, NJ, NY, OH, TN, VA and countries of AUSTRALIA, INDIA, JAPAN, MALAYSIA, NEW ZEALAND, PHILIPPINES and SINGAPORE.

Why it was recalled

Sterility compromised due to packaging pouches that may not be sealed properly

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Jamshidi Bone Marrow Biopsy/Aspiration Needle, with Luer Lock Adapter 11GX4 ASP, Sterile - Product Code: DJ4011X - Product Usage: The device is comprised of an outer cannula with a handle and an inner stylet. Its intended use is for the posterior iliac crest biopsy technique.