Class 2 Device Recall SureStep Foley Tray System

• Date Initiated by Firm: July 17, 2025
• Date Posted: September 18, 2025
• Recall Status: Open, Classified
• Recall Number: Z-2589-2025
• Recall Event ID: 97273
• 510(K)Number: K040658
• Product Classification: Catheter, urological (antimicrobial) and accessories - Product Code MJC
• Product: SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A
• Code Information: Lot#NGJX6399
• FEI Number: 1018233
• Recalling Firm/ Manufacturer: C.R. Bard Inc; 8195 Industrial Blvd Ne; Covington GA 30014-1497
• For Additional Information Contact: 770-784-6100
• Manufacturer 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
• FDA Determined Cause: Labeling mix-ups
• Action: 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
• Quantity in Commerce: 4,300
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = MJC