Medical device recalls Moderate risk

CIVCO Needle Guide 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 Needle Guide Bracket, REF 674-057, Reusable non-sterile bracket for use with SonoSite L25 series tranducers, Rx.
Recall number
Z-0574-2019
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 Needle Guide Bracket, REF 674-057, Reusable non-sterile bracket for use with SonoSite L25 series tranducers, Rx.

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