Medical Device Recall: 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 Complet
C.R. Bard Inc · June 25, 2026
Reason for Recall
Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
Product Description
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 REF: A800366C UDI-DI code: 00801741143571 SureStep" Foley Tray System Bard¿ Silicone Foley Catheter Tray REF: A897514C UDI-DI code: 00801741074011¿ SureStep" Foley Tray System Bard¿ Silicone Foley Catheter Tray REF: A897516C UDI-DI code: 00801741143595 SureStep" Foley Tray System Bard¿ Silicone Foley Catheter Tray REF: A902114C UDI-DI code: 00801741144325 ***** SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care REF: A300416AC UDI code: 00801741143281 10801741143288 SureStep" Foley Tray System Bardex¿ IC Complete Care REF: A303314AC UDI code: 00801741143304 10801741143301 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care REF: A319514AMC UDI code: 00801741143465 10801741143462 SureStep" Foley Tray System Bard¿ Lubricath¿ Foley Catheter Tray REF: A800061C UDI code: 00801741144172 10801741144179 SureStep" Foley Tray System Bard¿ Lubricath¿ Foley Catheter Tray REF: A800065C UDI code: 00801741144202 10801741144209 SureStep" Foley Tray System Bard¿ Lubricath¿ Foley Catheter Tray REF: A800360C UDI code: 00801741143519 10801741143516 SureStep" Foley Tray System Bard¿ Lubricath¿ Foley Catheter Tray REF:A800361C UDI code: 00801741143526 10801741143523 SureStep" Foley Tray System Bard¿ Lubricath¿ Foley Catheter Tray REF: A800362C UDI code: 00801741143540 10801741143547 SureStep" Foley Tray System Bard¿ Lubricath Foley REF: A800365C UDI code: 00801741143564 10801741143561 For urological use only, Intended for use in the drainage and/or collection and/or measurement of urine.
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, Costs Rica, Guatemala, Mexico, Saudi Arabia, and United Arab Emirates.
States Affected
NATIONWIDE
Quantity Affected
364
Source: FDA (openFDA Device Enforcement)
Recall number: Z-3119-2026
Status: ongoing
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