FDA recall Z-2888-2018

Civco Medical Instruments Co. Inc. · Class II · device

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.

Reason for recall

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

Distribution

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

Key facts

Status
Terminated
Initiation date
2018-02-23
Report date
2018-08-29
Termination date
2020-10-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Kalona, IA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2888-2018