Reported Sep 5, 2018 · Terminated

CIVCO Needle Guide, REF 676-150, QTY 24, STERILE EO

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 Needle Guide, REF 676-150, QTY 24, STERILE EO
Lot codes and dates
  • UDI 00841436107334
  • Lot numbers
    • A035054
    • A042207
Amount recalled
3 units

This recall covers 2 products

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

Why it was recalled

The assembly of the needle guides were found to be either missing adhesive or did not have adequate adhesive to hold the assembled cannula in place on the needle guide.

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 Sep 16, 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.