FDANovember 2, 2018device
CIVCO Needle Guide Bracket, REF P03122-06, Reusable non-sterile bracket for use with SonoSite L25/L25e transducers, Mfg by: CIVCO, Kalona, IA.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly.
What to do
FDA enforcement status: Terminated
Brands named
civco medical instrumentscivcocivco medical
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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