FDAOctober 21, 2015device
CIVCO Tracking Bracket Starter Kit, Reusable non-sterile PercuNav tracking bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REF 667-132. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Sterility of the product cannot be assured.
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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