Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0894-2017 — CARPAL TUNNEL PACK, Surgical Instrument Tray, REF/Catalog No. 3366, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Device Listing # D190549.

U.S. FDA — Device Enforcement · United States · 2016-11-15 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0894-2017
Date of alert
2016-11-15
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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