Medical device recalls Moderate risk

SonoSite 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 SonoSite Needle Guide Bracket, REF numbers P06013-06 and P06013-07, Reusable non-sterile bracket for use with SonoSite…
Recall number
Z-0566-2019
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

SonoSite Needle Guide Bracket, REF numbers P06013-06 and P06013-07, Reusable non-sterile bracket for use with SonoSite L25 series transducers.

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