Recall Z-3114-2026 ยท EZC Catheter, Coude
C.R. Bard Inc
Products that contain the Pericare Wipes: Bardex Lubricath Foley Catheter Tray REF: 899914 899916 899918 UDI codes: 00801741024801 10801741024808 00801741024818 10801741024815 00801741024825 10801741024822 SureStep" Foley Tray System with Bardex Lubricath Temp Sensing Foley Catheter REF: A119416M UDI code: 00801741073700 10801741073707 SureStep" Foley Tray System Bard Lubricath Foley REF: A800
| Date | Sep 4, 2026 (initiated Jun 25, 2026) |
| Status | Open, Classified |
| Reason | Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays. |
| Root cause | Under Investigation by firm |
| Action | On 06/25/2026, an "URGENT Medical Device Recall" Letter was via regional courier services or other electronic means to inform customers that based on customer feedback, BD has identified that the CliniClean Pericare Wipes provided within Urinary Catheter Trays may be potentially contaminated with an unknown non-biological substance. Customer are instructed to: Do not use CliniClean Pericare Wipes contained within the affected products listed in Attachment 2. The CliniClean Pericare Wipes are the only impacted component within the tray and all remaining components can continue to be safely use |
| Quantity | 12,463 trays/kits |
| Distribution | Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI and WY. The countries of Bahrain, Canada, Cos |
| FDA record | Open on fda.gov |