Reported Nov 25, 2015 · Terminated

CIVCO Sales Demo Kit. REF DEMOGPGUIDE Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter)…

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. · 102 1st St S · Kalona, IA · 52247-9589

Is this the product you have?

  • CIVCO Sales Demo Kit. REF DEMOGPGUIDE Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.
Lot codes and dates
    • M116270
    • M119900
    • M121920
    • M125640
    • M130290
    • M170900
    • M185950
    • M204790
    • M211280
    • M215550
    • M235410
    • M240880
    • M252870
    • M303130
    • M320620
    • M320660
    • M346050
    • M368820
    • M379870
    • M391260
    • M395270
    • M418200
    • M476020
    • M497220
    • M508200
    • M594740
    • M598320
    • and M624430
Amount recalled
54 boxes

This recall covers 5 products

The agency filed one notice per product. You are reading one of them; the other 4 are below.

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Sterility of the product cannot be assured.

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

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Feb 28, 2017 · Data as of Sep 19, 6:01 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.