FDANovember 15, 2016device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

robert busse co inc d b a busse hospital disposablesrobertrobert busse

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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