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 674-038, Reusable non-sterile bracket with sterile needle guide (1cm, 1.5cm, 2cm de…
- Recall number
- Z-0572-2019
- 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 674-038, Reusable non-sterile bracket with sterile needle guide (1cm, 1.5cm, 2cm depths) with (10.2 x 147cm) CIV-Flex cover for use with SonoSite L25 series transducers, 21 GAUGE, Rx. The firm name on the label is CIVCO, Kalona, IA..
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