SureStep Foley Tray System BARD¿ Lubri-Sil Foley Catheter Tray, REF: A942216
FDA Recall #Z-2591-2025 — Class II — July 17, 2025
Product Description
SureStep Foley Tray System BARD¿ Lubri-Sil Foley Catheter Tray, REF: A942216
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
3670
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# NGJX4320
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated