SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: ...
FDA Recall #Z-2589-2025 — Class II — July 17, 2025
Product Description
SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A
Reason for Recall
Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel with antimicrobial coating, or 3)Natural latex with infection control, when it's silicone hydrogel coated without antimicrobial coating, which may cause infection and/or local and/or systemic allergic reaction
Recalling Firm
C.R. Bard Inc — Covington, GA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
4,300
Distribution
US Nationwide distribution including in the states of NC, FL, NY, MA, MN, TX, CA, OH, MI, WA, NJ, IL, ID, SC, IN, OK, OR, AL, VA, HI, MO, MS, MD, AZ, KY, GA, IA, CO, NM, PA, ME, UT, NE.
Code Information
Lot#NGJX6399
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated