Medical device recalls Moderate risk

CIVCO Needle Guide Starter Kit 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 Starter Kit, REF 674-039, Reusable non-sterile bracket with sterile needle guides (1cm, 1.5cm, 2cm d…
Recall number
Z-0573-2019
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 Starter Kit, REF 674-039, Reusable non-sterile bracket with sterile needle guides (1cm, 1.5cm, 2cm depths) with (10.2 x 147cm) CIV-Flex cover for use with SonoSite L25 series transducers, 22 GAUGE, Rx.

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