FDADecember 6, 2018device
BARD SureStep Foley Tray System Bardex I.C. Complete Care Temperature Sensing Infection Control Foley Catheter with Bard Hydrogel and Bacteria-Guard Silver Alloy Coating. Sterile. Intended for use in the drainage and/or collection and/or measurement of urine.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Some SureStep" Foley Tray Systems with product catalog number A319418AM and lot number NGCT1929 contain vented sample ports that may have an increased likelihood of leaking urine from the vent on the sample port.
What to do
FDA enforcement status: Ongoing
Brands named
bard medical divisionbardbard medical
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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