Z-2589-2025Class II

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

Name: Z-2589-2025 SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A
Creator: C.R. Bard Inc
Published: 2025-07-17
License: https://open.fda.gov/license/

C.R. Bard Inc / initiated 2025-07-17 / Open, Classified / root cause: labeling and UDI

FDA source

C.R. Bard Inc began a recall of SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A on 2025-07-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2589-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-07-17
Posted: 2025-09-18
Recalling firm: C.R. Bard Inc
Product: SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A
Product code: MJC Catheter, Urological (Antimicrobial) And Accessories
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
Root cause tag: labeling and UDI
FDA root 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 [email protected] 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, [email protected]; Technical Support: 1-844-823-5433, [email protected]
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.
Product codes and lots: Lot#NGJX6399

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2589-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2589-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-24	2025-09-18
Z-2590-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-24	2025-09-18
Z-2591-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-24	2025-09-18

Product code MJC

K040658Class IIBardex I.c. Latex Foley CatheterC.R. Bard, Inc. / cleared 2004-09-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)