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BARD SureStep Foley Tray System Bardex I.C. Complete Care Temperature Sensing Infection Control F...

FDA Recall #Z-0800-2019 — Class II — December 6, 2018

Recall #Z-0800-2019 Date: December 6, 2018 Classification: Class II Status: Ongoing

Product Description

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.

Reason for Recall

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.

Recalling Firm

Bard Medical Division — Covington, GA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

450 units

Distribution

US Nationwide Distribution io KY, NE, GA, FL, MS, IN, IL, VA, OK, TX, NM, IL, VA, PA, CA, NV.

Code Information

Product Code A319418AM; Lot NGCT1929; Exp. Date 11/30/2018

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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