Recall Z-3117-2026— C.R. Bard Inc
Class II · Ongoing
Class II FDA medical device recall by C.R. Bard Inc, initiated 2026-06-25. It names 2 FDA 510(k) clearances: K000723, K802665. 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: Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays..
- Recalling firm
- C.R. Bard Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-06-25
- Firm location
- Covington, GA, United States
510(k) clearances named in this recall
2 on FDA's record- K000723 — HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC)
- K802665 — TOUCHLESS CLEAN-CATH
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.