# FDA recall Z-2888-2018

> **Civco Medical Instruments Co. Inc.** · Class II · device recall initiated 2018-02-23.

## 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

- **Recall number:** Z-2888-2018
- **Recalling firm:** Civco Medical Instruments Co. Inc.
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-2888-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-2888-2018. Source: US FDA. Licensed CC0.

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