Class IIDeviceOngoing

C.R. Bard Inc

Products that contain the Pericare Wipes: *Bardex¿ I.C. Complete Care¿ Foley Catheter Tray REF: 300316A UDI codes: 00801741024344¿ 10801741024341 *Bardex¿ I.C. Complete Care¿ Foley Catheter Tray and Urine Meter REF: 303314A 303316A 303318A UDI code: 00801741024252¿ 10801741024259 00801741024269 10801741024266 00801741024276¿ 10801741024273 *SureStep" Foley Tray System Bardex¿ IC Complete Care¿ REF: A300314A UDI codes: 00801741073724¿ 10801741073721 REF: A300314AC (Canada Only) UDI-DI code: 00801741143243 *SureStep" Foley Tray System Bardex¿ IC Complete Care¿ REF: A300316A UDI code: 00801741073731 10801741073738 *SureStep" Foley Tray System Bardex¿ IC Complete Care¿ REF: A300318A UDI code: 00801741073748¿ 10801741073745 *SureStep" Foley Tray System Bardex¿ IC Complete Care¿ REF: A303314A A303316A A303318A UDI code: 00801741073786¿ 10801741073783 00801741073793¿ 10801741073790 00801741073809¿ 10801741073806 *SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ REF: A303414A UDI code: 00801741073816¿ 10801741073813 *(416A)SureStep" Foley Tray System Bardex¿ IC Complete Care¿ (714A/716A/718A)SureStep" Foley Tray System Bardex¿ IC Complete Care¿ (914)SureStep" Foley Tray System REF: A304716A A304714A A304716A A304718A UDI code: 00801741104206¿ 10801741104203 00801741104268 10801741104265 00801741104299¿ 10801741104296 00801741100376¿ 10801741100373 *SureStep" Foley Tray System Bardex¿ IC Complete Care¿ REF: A319416A UDI code: 00801741100307¿ 10801741100304 *SureStep" Foley Tray System Bardex¿ I.C. Complete Care Foley Catheter REF: A319416AM UDI code: 00801741073861¿ 10801741073868 *SureStep" Foley Tray System Bardex¿ IC Complete Care¿ REF: A319418A UDI code: 00801741100314¿ 10801741100311 SureStep" Foley Tray System Bardex¿ IC Complete Care¿ REF: A903316A UDI code: 00801741096600¿ 10801741096607 ***** SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care REF: A300414A UDI code: 00801741073755 10801741073752 SureStep" Foley Tray System Bardex¿ I.C. Complete Care Foley Catheter REF: A319414AM UDI code: 00801741073854 10801741073851 SureStep" Foley Tray System Bardex¿ I.C. Complete Care Foley Catheter REF: A319418AM UDI code: 00801741073878 10801741073875 SureStep" Foley Tray System Bardex¿ IC Complete Care REF: A903318A UDI code: 00801741104657 10801741104654 For urological use only, Intended for use in the drainage and/or collection and/or measurement of urine.

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.

Details

Recall number: Z-3116-2026
Event ID: 98840
Recall initiated: Jun 25, 2026
Classified: Sep 4, 2026
Reported: Sep 16, 2026
Quantity: 212580
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.
Initiated by: Voluntary: Firm initiated
Firm notification: Letter
Firm location: Covington, GA, United States
Lot / code info: Bardex¿ I.C. Complete Care¿ Foley Catheter Tray 300316A / 00801741024344¿ 10801741024341 Lot Number: NGKT3657 Bardex¿ I.C. Complete Care¿ Foley Catheter Tray and Urine Meter 303314A / 00801741024252¿ 10801741024259 Lot Number: NGKU4153 303316A / 00801741024269 10801741024266 Lot Number: NGKW2883 303318A / 00801741024276¿ 10801741024273 Lot Number: NGKU0966 *SureStep" Foley Tray System Bardex¿ IC Complete Care¿ A300314A / 00801741073724¿ 10801741073721 Lot Number: NGKU1020 A300314AC (Canada Only) / 00801741143243 Lot Number: **** SureStep" Foley Tray System Bardex¿ IC Complete Care¿ A300316A / 00801741073731 10801741073738 Lot Numbers: NGKT2448 NGKT3221 NGKT3288 NGKT3301 NGKT3315 NGKU2921 NGKV0293 SureStep" Foley Tray System Bardex¿ IC Complete Care¿ A300318A / 00801741073748¿ 10801741073745 Lot Number: NGKT2493 SureStep" Foley Tray System Bardex¿ IC Complete Care¿ A303314A / 00801741073786¿ 10801741073783 Lot Numbers: NGKT3222 NGKV0249 A303316A / 00801741073793¿ 10801741073790 Lot Numbers: NGKU0894 NGKU0947 NGKU0973 NGKU1021 NGKU1748 NGKU1826 NGKU1830 NGKU2034 NGKU2035 NGKU2996 NGKU3042 NGKU3969 NGKU4037 NGKU4077 NGKU4078 NGKU4135 NGKU4713 NGKU4714 NGKU4720 NGKU4721 NGKU4722 NGKU4727 NGKV2390 NGKV3390 A303318A / 00801741073809¿ 10801741073806 Lot Numbers: NGKT3223 NGKU4136 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ A303414A / 00801741073816¿ 10801741073813 Lot Number: NGKU1022 (416A)SureStep" Foley Tray System Bardex¿ IC Complete Care¿ (714A/716A/718A)SureStep" Foley Tray System Bardex¿ IC Complete Care¿ (914)SureStep" Foley Tray System A304716A / 00801741104206 10801741104203 Lot Number: NGKT2496 A304714A / 00801741104268 10801741104265 Lot Number: NGKU2923 A304716A / 00801741104299 10801741104296 Lot Numbers: NGKU1833 NGKU4729 A304718A / 00801741100376¿ 10801741100373 Lot Numbers: NGKT3224 NGKU3971 SureStep" Foley Tray System Bardex¿ IC Complete Care¿ A319416A / 00801741100307¿ 10801741100304 Lot Number: NGKS1605 SureStep" Foley Tray System Bardex¿ I.C. Complete Care Foley Catheter A319416AM / 00801741073861¿ 10801741073868 Lot Numbers: NGKT2390 NGKT2410 NGKT3225 NGKT3319 NGKU0951 NGKU0977 SureStep" Foley Tray System Bardex¿ IC Complete Care¿ A319418A / 00801741100314¿ 10801741100311 Lot Number: NGKT2411 SureStep" Foley Tray System Bardex¿ IC Complete Care¿ A903316A / 00801741096600¿ 10801741096607 Lot Numbers: NGKT3392 NGKU2020 **** SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care A300414A / 00801741073755 10801741073752 Lot Number: NGKV3524 SureStep" Foley Tray System Bardex¿ I.C. Complete Care Foley Catheter A319414AM / 00801741073854 10801741073851 Lot Number: NGKV3487 SureStep" Foley Tray System Bardex¿ I.C. Complete Care Foley Catheter A319418AM / 00801741073878 10801741073875 Lot Number: NGKV4983 SureStep" Foley Tray System Bardex¿ IC Complete Care A903318A / 00801741104657 10801741104654 Lot Number: NGKV2397