Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables product recalled over foreign material

Recall date

June 27, 2017

Source

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

Official notice title

Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables recalls Safety Deluxe Bone Marrow Biopsy/ Aspiration Tray with Biopsy Needle and Aspiration Needle Sterile, Catalog # 985 Produ…

Recall number

Z-0543-2018

FDA classification

Class II

Brand / firm

Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables

Sold / distributed

US Nationwide Distribution

Why it was recalled

BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification.

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

What was recalled

Safety Deluxe Bone Marrow Biopsy/ Aspiration Tray with Biopsy Needle and Aspiration Needle Sterile, Catalog # 985 Product Usage: Surgical procedure