FDA-Device2018-12-19Class II
CIVCO Needle Guide Bracket, REF P03122-06, Reusable non-sterile bracket for use with SonoSite L25/L25e transducers, Mfg by: CIVCO, Kalona, IA.
CIVCO Medical Instruments Co., Inc.
Hazard
The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly.
Sold states
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.
Affected count
948 boxes
Manufactured in
2301 Jones Blvd, N/A, Coralville, IA, United States
Products
CIVCO Needle Guide Bracket, REF P03122-06, Reusable non-sterile bracket for use with SonoSite L25/L25e transducers, Mfg by: CIVCO, Kalona, IA.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0564-2019Don't want to check this manually?
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