Reported Dec 19, 2018 · Terminated

CIVCO Needle Guide Bracket, REF 674-057-10, Reusable non-sterile bracket for use with FUJIFILM SonoSite, Inc. L25…

CIVCO Medical Instruments Co., Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: CIVCO Medical Instruments Co., Inc. · 2301 Jones Blvd · Coralville, IA · 52241-3469

Is this the product you have?

  • CIVCO Needle Guide Bracket, REF 674-057-10, Reusable non-sterile bracket for use with FUJIFILM SonoSite, Inc. L25 series tranducers, Rx.
Lot codes and dates
  • Boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, and all brackets in inventory that no longer have the product labeling.
Amount recalled
3 boxes

This recall covers 15 products

The agency filed one notice per product. You are reading one of them; the other 14 are below.

2 more are in the archive.

Why it was recalled

The notice does not describe the hazard.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Nov 20, 2020 · Data as of Sep 19, 5:22 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.