C.R. Bard Inc: Device Recall

Recall #Z-2589-2025 · 07/17/2025

Class II: Risk

Recall Details

Recall Number
Z-2589-2025
Classification
Class II
Product Type
Device
Recalling Firm
C.R. Bard Inc
Status
Ongoing
Date Initiated
07/17/2025
Location
Covington, GA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4,300

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

Product Description

SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A

Distribution Pattern

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.

Other Recalls by C.R. Bard Inc

View all recalls by C.R. Bard Inc →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.