Angiotech (Manan Medical Products, Inc.) recalls J Type Bone Marrow Needle 13ga x 6cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.

Recall date

December 18, 2018

Source

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

Recall number

Z-0816-2019

FDA classification

Class II

Brand / firm

Angiotech (Manan Medical Products, Inc.)

Sold / distributed

Worldwide distribution - US Nationwide in the states of New Jersey, and countries of Mexico and South Korea.

Why it was recalled

Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line

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

What was recalled

J Type Bone Marrow Needle 13ga x 6cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.