Products that contain the Pericare Wipes: SureStep" Foley Tray System Add-A-Foley Catheter REF: A153200 UDI code: 00801741121067¿ 10801741121064 SureStep" Foley Tray System Complete Care¿ Add-A-Foley Catheter REF: A304400A UDI code: 00801741073847¿ 10801741073844 SureStep" Foley Tray System Add-A-Foley Catheter REF: A399400 UDI code: 00801741100369¿ 10801741100366 SureStep" Foley Tray System Complete Care¿ Add-A-Foley Catheter REF: A399400A UDI code: 00801741073915¿ 10801741073912 SureStep" Foley Tray System Complete Care¿ Add-A-Foley Catheter REF: A904400A UDI code: 00801741074097¿ 10801741074094 SureStep Intermittent Catheter Tray REF: INTAAI UDI code: 00801741183317 10801741183314 For urological use only, Intended for use in the drainage and/or collection and/or measurement of urine.
Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
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.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3118-2026