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Civco Medical Instruments Co. Inc. recalls CIVCO lnfiniti Needle Guide Bracket. used for performing needle-guided (or catheter) procedures with the use of diagnost
Recalled August 29, 2018 · FDA recall Z-2888-2018 · Civco Medical Instruments
Hazard
A cover failed leak testing during validation testing of new needle guides from a replacement tool. · FDA Class II
Units
177 boxes
Sold at
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
Description
A cover failed leak testing during validation testing of new needle guides from a replacement tool.
Product
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.
Manufacturer(s)
Civco Medical Instruments Co. Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →