medical Class II Updated 2019-02-13

Bard Medical Division recalls BARD SureStep Foley Tray System Bardex I.C. Complete Care Te

Recalled Product

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.

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Product Code A319418AM; Lot NGCT1929; Exp. Date 11/30/2018
View official government recall

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