Civco Medical Instruments Co. Inc. recalls CIVCO lnfiniti Needle Guide Bracket. used for performing needle-guided (or catheter) procedures with the use of diagnos…

Recall date

February 23, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2888-2018

FDA classification

Class II

Brand / firm

Civco Medical Instruments Co. Inc.

Sold / distributed

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

Why it was recalled

A cover failed leak testing during validation testing of new needle guides from a replacement tool.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.