Teleflex Medical recalls ARROW OnControl Bone Marrow Biopsy System Comprehensive Tray, Sterile, The Arrow OnControl Bone Marrow Aspiration Syste…

Recall date

November 8, 2016

Source

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

Recall number

Z-0676-2017

FDA classification

Class II

Brand / firm

Teleflex Medical

Sold / distributed

Worldwide Distribution - US (nationwide) Internationally to Brazil, Canada, Ecuador, Guatemala, Mexico and Peru.

Why it was recalled

Sterility: Due to a potential incomplete seal on the outer sterile package.

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

What was recalled

ARROW OnControl Bone Marrow Biopsy System Comprehensive Tray, Sterile, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow¿ OnControl Bone Marrow Biopsy System is intended for bone marrow core biopsy of the anterior or posterior iliac crest of adult patients