Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

CIVCO lnfiniti Needle Guide Bracket. used for performing needle-guided (or Recalled by Civco Medical Instruments Co. Inc. Due to A cover failed leak testing during validation testing...

Date: February 23, 2018
Company: Civco Medical Instruments Co. Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Civco Medical Instruments Co. Inc. directly.

Affected 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.

Quantity: 177 boxes

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Civco Medical Instruments Co. Inc.

Civco Medical Instruments Co. Inc. has 13 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report