Medical device recalls Moderate risk

CIVCO Biopsy Bracket recalled over sterility concerns

Recall date
November 2, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
CIVCO Medical Instruments Co., Inc. recalls CIVCO Biopsy Bracket, REF P03122-07, Reusable non-sterile single-angle bracket for use with SonoSite L25 series transdu…
Recall number
Z-0565-2019
FDA classification
Class II
Brand / firm
CIVCO Medical Instruments Co., Inc.
Sold / distributed
Foreign distribution was made to Canada, Argentina, Australia, Austria, Belgium, Brazil, Chile, China, Colombia, Croatia, Cyprus, Denmark, Estonia, France, Germany, Hong Kong, India, Israel, Italy, Japan, Latvia, Lebanon, Lithuania, Netherlands, New Zealand, Philippines, Poland, Portugal, Qatar, Ro…

What was recalled

CIVCO Biopsy Bracket, REF P03122-07, Reusable non-sterile single-angle bracket for use with SonoSite L25 series transducers.

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