CIVCO Needle Guide Bracket recalled over sterility concerns

Recall date

November 2, 2018

Source

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

Official notice title

CIVCO Medical Instruments Co., Inc. recalls CIVCO Needle Guide Bracket, REF numbers M001457100, P06013-10, and P03122-08, reusable non-sterile single-angle bracket…

Recall number

Z-0562-2019

FDA classification

Class II

Brand / firm

CIVCO Medical Instruments Co., Inc.

Sold / distributed

Foreign distribution was made to Canada, Argentina, Australia, Austria, Belgium, Brazil, Chile, China, Colombia, Croatia, Cyprus, Denmark, Estonia, France, Germany, Hong Kong, India, Israel, Italy, Japan, Latvia, Lebanon, Lithuania, Netherlands, New Zealand, Philippines, Poland, Portugal, Qatar, Ro…

Why it was recalled

The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly.

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 Bracket, REF numbers M001457100, P06013-10, and P03122-08, reusable non-sterile single-angle bracket for use with SonoSite L25 series tranducers, RX. The firm name on the label is CIVCO, Kalona, IA.