Recall Z-3117-2026
- Recall number
- Z-3117-2026
- Event number
- 98840
- Firm
- C.R. Bard Inc
- Firm FEI
- 1018233
- Product code
- KOD
- Status
- Open, Classified
- Initiated
- 2026-06-25
- Posted
- 2026-09-04
- Root cause
- Under Investigation by firm
- 510(k) numbers
- K000723, K802665, K013345, K850790, K854625, K833432, K033023, K853337, K780676, K896750, K820419, K863282, K820637, K810630, K841485, K831743, K890400, K842890, K761059, K896385, K870977, K896208, K032710, K860265, K841727, K861181, K851160, K896784, K871297, K853207
Product#
Products that contain the Pericare Wipes: SureStep Intermittent Catheter Tray REF: INTP16 INTS14 INTS14C INTS16 INTS16C PEDINTS06 PEDINTS08 PEDINTS10 UDI code: 00801741183300 10801741183307 00801741183218 10801741183215 00801741183232 10801741183239 00801741183225 10801741183222 00801741183249 10801741183246 00801741183263 10801741183260 00801741183270 10801741183277 00801741183287 10801741183284 Preamendment REF: INTL14 INTL15 INTL16 INTP14 UDI code: 00801741183164 10801741183161 00801741183171 10801741183178 00801741183188 10801741183185 00801741183294 10801741183291 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.