Civco Medical Instruments Co. Inc. recalls CIVCO Needle Guide, REF 676-144, QTY 24, STERILE EO

Recall date

July 30, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2946-2018

FDA classification

Class II

Brand / firm

Civco Medical Instruments Co. Inc.

Sold / distributed

United States, Austria, Belgium, Denmark, France, Germany, Poland, Spain, Switzerland and United Kingdom

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

CIVCO Needle Guide, REF 676-144, QTY 24, STERILE EO