Recall Z-2590-2025 ยท MJC Catheter, Urological (Antimicrobial) And Accessories
C.R. Bard Inc
SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303414A
| Date | Sep 18, 2025 (initiated Jul 17, 2025) |
| Status | Open, Classified |
| Reason | 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 | 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 p |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040658 | BARDEX I.C. LATEX FOLEY CATHETER C.R. Bard, Inc., Sep 29, 2004 |