Recall Z-3118-2026
- Recall number
- Z-3118-2026
- Event number
- 98840
- Firm
- C.R. Bard Inc
- Firm FEI
- 1018233
- Product code
- KNX
- Status
- Open, Classified
- Initiated
- 2026-06-25
- Posted
- 2026-09-04
- Root cause
- Under Investigation by firm
- 510(k) numbers
- K791252, K820565, K871042, K921024, K801711, K781422, K812252, K843479, K861192, K830946, K770557, K770490, K812058, K840702, K833570, K873136, K821829, K802606, K761360, K840292, K812249, K780831, K892433, K813621, K833245, K802172, K842257, K862580, K791265, K770399
Product#
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.
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.