Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables recalls SET UP PACK Surgical Instrument Tray, REF/Catalog No. 6250R1, STERILE, Rx Only --- busse Hospital Disposables Hauppauge…

Recall date

November 15, 2016

Source

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

Recall number

Z-0896-2017

FDA classification

Class II

Brand / firm

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

Sold / distributed

PA, FL, VA

Why it was recalled

Covidien issued a labeling update for the Covidien Devon Light Gloves. Busse had incorporated the affected gloves in several kits and distributed them prior to receipt of the recall notification.

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

What was recalled

SET UP PACK Surgical Instrument Tray, REF/Catalog No. 6250R1, STERILE, Rx Only --- busse Hospital Disposables Hauppauge, NY --- Device Listing # A343147