Recall Z-2462-2025 ยท EZL Catheter, Retention Type, Balloon
C.R. Bard Inc
Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated All-Silicone Foley Catheter 5cc Balloon, REF: 119314; SureStep Foley Tray System Lubri-Sil I.C. Complete Care, REF: A319514A; Bard Silver Lubri-Sil Foley Tray Temperature Sensing with Bard Hydrogel and Bacti-Guard Silver Alloy Coating, 14Fr, REF: 29000J14, 29030J14, 29000J14S; Bard Silver Lubri-Sil Foley Tray Temperature
| Date | Aug 28, 2025 (initiated Jun 18, 2025) |
| Status | Open, Classified |
| Reason | Foley catheter may have an obstructed lumen, which may result in an inability to drain the bladder, of urine and may include pelvic or abdominal pain, flank pain, bladder dysfunction, obstructive uropathy, acute kidney injury and/or hydronephrosis. |
| Root cause | Process design |
| Action | On 6/18/2025, recall notices were mailed or emailed to Recall Coordinators, Directors of Nursing, Purchasing, Risk Management, and distributors who were informed the following: The affected product was distributed from 07 March 2024 to 14 May 2025. - If affected product is currently indwelling and draining urine appropriately, the catheter does not need to be removed. - For affected product currently not in use, quarantine, and dispose of unused product and source alternative product. - Share this notice with any users of the product within your facilities to ensure they are also aware of |
| Quantity | 175,158 |
| Distribution | Worldwide - US Nationwide distribution in the states of IA, PA, AR, OR, MN, IN, WV, OK, AL, MD, HI, GA, AZ, MA, FL, CA and the countries of Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070582 | BARDEX ALL-SILICONE, BARDEX LUBRI-SIL, AND BARDEX LUBRI-SIL I.C. TEMPERATURE-SENSING FOLEY CATHETERS C.R. Bard, Inc., Dec 7, 2007 |