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 numbers P12920-01 and P12920-02, Reusable non-sterile bracket with sterile (1.5cm,…
- Recall number
- Z-0568-2019
- 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 numbers P12920-01 and P12920-02, Reusable non-sterile bracket with sterile (1.5cm, 2.5cm, 3.5cm, 4.5cm depths) needle guides (5), (10.2 x 147cm) CIV-Flex covers ((5) for use with SonoSite L25 series transducers, 18 GAUGE, Rx.
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