This is part of a larger recall. The most authoritative record is FDA-Device / Z-3116-2026.
FDA-Device2026-09-16Class IIPACKAGING DEFECT
C.R. Bard Foley and Intermittent Catheter Trays recalled for contaminated Pericare Wipes
What this means
C.R. Bard has recalled multiple Foley and Intermittent Catheter Trays because the Pericare Wipes included in these kits may have contamination on their surface. The affected trays are used for urine drainage, collection, and measurement. No injuries have been reported.
- Check if you have one of the affected catheter trays by comparing your product reference number or UDI code to the FDA recall notice.
- Do not use the Pericare Wipes from affected trays.
- Contact your healthcare provider or C.R. Bard for instructions on obtaining replacement wipes or trays.
- Return or dispose of affected products as directed by your healthcare provider or the manufacturer.
The agency's original wording
Hazard
Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
12,463 trays/kits
Manufactured in
8195 Industrial Blvd Ne, Covington, GA, United States
Products
Products that contain the Pericare Wipes: Bardex Lubricath Foley Catheter Tray REF: 899914 899916 899918 UDI codes: 00801741024801¿ 10801741024808 00801741024818¿ 10801741024815 00801741024825¿ 10801741024822 SureStep" Foley Tray System with Bardex¿ Lubricath Temp Sensing Foley Catheter REF: A119416M UDI code: 00801741073700 10801741073707 SureStep" Foley Tray System Bard¿ Lubricath Foley REF: A800361 UDI code: 00801741073939 10801741073936 SureStep" Foley Tray System Bard¿ Lubricath¿ Foley Catheter Tray REF: A899616 UDI code: 00801741104534¿ 10801741104531 SureStep" Foley Tray System Bardex¿ Lubricath¿ Foley Catheter REF: A899914 UDI code: 00801741074004 10801741074001 SureStep" Foley Tray System Bardex¿ Lubricath¿ Foley Catheter REF: A899916 UDI code: 00801741074011¿ 10801741074018 SureStep" Foley Tray System Bardex¿ Lubricath¿ Temperature Sensing Catheter REF: A900216 UDI code: 00801741120978¿ 10801741120975 SureStep" Foley Tray System Bard¿Lubricath¿ Foley Catheter REF: A902914 A902916 A902918 UDI code: 00801741074066¿10801741074063 00801741074073 10801741074070 00801741074080¿10801741074087 Bard¿ Urine Meter Foley Catheter Tray With Bardex¿ Lubricath¿ Foley Catheter REF: 304916 UDI code: 00801741019736 01801741019739 Bard¿ Urine Meter Foley Catheter Tray With Bardex¿ Lubricath¿ Foley Catheter REF: 902916 UDI codes: 00801741024863 10801741024860 (416A) SureStep Foley Tray System Bardex IC Complete Care (714A/716A/718A)SureStep Foley Tray System Bardex IC Complete REF: A304914 A304916 A304918 UDI codes: 00801741104350¿ 10801741104357 00801741104367¿ 10801741104364 00801741100499¿ 10801741100496 SureStep" Foley Tray System Bard¿ Lubricath Foley REF: A800365 UDI codes: 00801741073960 10801741073967 SureStep" Foley Tray System Bardex¿ Lubricath¿ Foley Catheter REF: A899918 UDI codes: 00801741074028 10801741074025 SureStep" Foley Tray System Bard¿Lubricath¿ Foley Catheter REF: A902618 UDI codes: 00801741104640 10801741104647 SureStep" Foley Tray System Bard¿Lubricath¿ Foley Catheter REF: A902616 UDI codes: 00801741104633¿ 10801741104630 SureStep Intermittent Catheter Tray REF: INTL16C UDI codes: 00801741183195¿ 10801741183192 For urological use only, Intended for use in the drainage and/or collection and/or measurement of urine.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3114-2026Want us to check the next one for you?
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