Medical device recalls Moderate risk

Cook product recalled over fire hazard

Recall date
March 7, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Cook Inc. recalls Bush DL Ureteral Illuminating Catheter Set Bush SL Ureteral Illuminating Catheter Set
Recall number
Z-1870-2017
FDA classification
Class II
Brand / firm
Cook Inc.
Sold / distributed
The devices have been distributed within the United States and the following countries: Bahamas, Belgium, Brazil, Canada, Chile, China, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, Ireland, Israel, Italy, Jers…

Why it was recalled

Product may overheat, melt, and burn patient.

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

What was recalled

Bush DL Ureteral Illuminating Catheter Set Bush SL Ureteral Illuminating Catheter Set

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