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 P03122-06, Reusable non-sterile bracket for use with SonoSite L25/L25e transducers, Mfg…
- Recall number
- Z-0564-2019
- 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 P03122-06, Reusable non-sterile bracket for use with SonoSite L25/L25e transducers, Mfg by: CIVCO, Kalona, IA.
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