Recall Z-3119-2026 ยท KNX Collector, Urine, (And Accessories) For Indwelling Catheter
C.R. Bard Inc
Products that contain the Pericare Wipes: (Canada Only) SureStep" Foley Tray System Bardex IC Complete Care REF: A300314AC UDI-DI code: 00801741143243 SureStep" Foley Tray System Bardex IC Complete Care REF: A300316AC UDI-DI code: 00801741143250 SureStep" Foley Tray System Lubri-Sil IC Complete Care REF: A319516AMC UDI-DI code: 00801741143472 SureStep" Foley Tray System Bard Lubricath Foley RE
| 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 | 364 |
| 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 |
510(k) clearances named in this recall
This recall record lists no 510(k) number.