FDA-Device2018-08-29Class II
CIVCO lnfiniti Needle Guide Bracket. used for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers. Product Usage: The bracket and disposable guide provide physicians with a tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers.
Civco Medical Instruments Co. Inc.
Hazard
A cover failed leak testing during validation testing of new needle guides from a replacement tool.
Sold states
Worldwide Distribution - US Nationwide in the states of GA, KY, CA, NY , NJ, TX, IL, MA, RI, AZ, and IA and countries of Ukraine, Hong Kong, Italy, Netherlands, Switzerland, United Kingdom, Denmark, Germany, Belgium, Spain, Japan, China, and Canada
Affected count
177 boxes
Manufactured in
102 1st St S, Kalona, IA, United States
Products
CIVCO lnfiniti Needle Guide Bracket. used for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers. Product Usage: The bracket and disposable guide provide physicians with a tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2888-2018Don't want to check this manually?
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