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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 dep
Recalled December 19, 2018 · FDA recall Z-0572-2019 · CIVCO Medical Instruments
Hazard
FDA Class II
Units
613 boxes
Sold at
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, Romania, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Trinidad/Tobago, Turkey, Ukraine, United Arab Emirates, and the United Kingdom.
Product
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..
Manufacturer(s)
CIVCO Medical Instruments Co., Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →