C.R. Bard Inc recalls SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303414A

Recall date

July 17, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2590-2025

FDA classification

Class II

Brand / firm

C.R. Bard Inc

Sold / distributed

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.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303414A