Medical device recalls Moderate risk

Cook Inc. recalls Clarke-Reich Laparoscopic Knot Pusher

Recall date
April 25, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2537-2017
FDA classification
Class II
Brand / firm
Cook Inc.
Sold / distributed
The devices have been distributed nationwide within the United States and the following countries: Australia, Belgium, Canada, Finland, Germany, Guatemala, Hong Kong, India, Ireland, Japan, South Korea, Kuwait, Malaysia, Netherlands, New Zealand, Puerto Rico, Saudi Arabia, Taiwan, and the United Ki…

Why it was recalled

reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products

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

What was recalled

Clarke-Reich Laparoscopic Knot Pusher

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