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 1080
Check against the official notice below — it lists the full affected range.
Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
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. 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. Quantity: 212580 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"
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.