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

FDA device recall Z-2589-2025 · posted 2025-09-18 · Open, Classified

Recall details

Recalling firm

C.R. Bard Inc

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

Action taken

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

Root cause

Labeling mix-ups

Status

Open, Classified

Product code

MJC

Quantity affected

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.

Date initiated

2025-07-17

Date posted

2025-09-18

Location

Covington, GA

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