Medical device recalls Moderate risk

Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables recalls CARPAL TUNNEL PACK, Surgical Instrument Tray, REF/Catalog No. 3366, STERILE, Rx Only -- busse Hospital Disposables Haup…

Recall date
November 15, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0894-2017
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

CARPAL TUNNEL PACK, Surgical Instrument Tray, REF/Catalog No. 3366, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Device Listing # D190549.

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