C.R. Bard Inc recalls SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray

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

On 7/17/2025, recall notices were mailed and emailed to Recall Coordinator, Director of Nursing, Director of Purchasing, Director of Risk Management, and Distributors who were asked to do the following: 1) It is recommended that clinicians discontinue the use of impacted devices and find alternative catheters with the appropriate characteristics required for their patients to continue therapy and avoid potential health risks related to this issue. 2) Quarantine and discard all devices within your facility s control per your facility s procedures. 3) Share this notice with any users of the product within your facilities to ensure they are also aware of this Medical Device Recall (Correction). 4) If you have purchased this product through a distributor, please contact this distributor to request appropriate credit or order alternate replacement product. 5) Complete and return the attached Customer Response Form via email to BDRC38@bd.com In addition, distributors were asked to: a) Identify all customers within your distribution network that purchased any affected product as defined in this notification. Provide a copy of the attached customer letter to all customers to advise them of this field action notification on the recalling firm's behalf. b) Contact recalling firm if you require assistance with credits to be issued for discard-ed products or for replacement product options. If you require assistance contact the firm: Medical Information Services: 1-800-555-7422, medical.information@bd.com; Technical Support: 1-844-823-5433, productcomplaints@bd.com

• FDA enforcement recordOfficial FDA database entry for Z-2589-2025
• FDA 510(k) clearance · K040658The device's official FDA premarket clearance record
• FDA device classification · MJCOfficial FDA classification for this device type
• CFR regulation · 21 CFR 876.5130The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find C.R. Bard IncSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.