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C.R. Bard Inc recalls SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A
Recalled September 24, 2025 · FDA recall Z-2589-2025 · C.R. Bard
Hazard
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 · FDA Class II
Units
4,300
Sold at
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.
Description
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
Product
SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A
Manufacturer(s)
C.R. Bard Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →