Class II — C.R. Bard Inc
| Recalling firm | C. R. Bard, Inc. |
|---|---|
| Registered facility | View this company's 19 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays. |
| Product | Products that contain the Pericare Wipes: Bard® Foley Tray With Lubri-Sil® All-Silicone Foley Catheter REF: 947314 947316 947318 UDI codes: 00801741024924® 10801741024921 00801741024931® 10801741024938 00801741024948® 10801741024945 Lubri-Sil® I.C. Complete Care® All-Silicone Foley Catheter Tray REF: 300416A UDI code: 00801741024580 10801741024587 SureStep" Foley Tray System Lubri-Sil® IC Complete Care® REF: A300416A UDI code: 00801741073762® 10801741073769 SureStep" Foley Tray System Lubri-Sil® IC Complete Care REF: A303416A UDI code: 00801741073823 10801741073820 SureStep" Foley Tray … |
| Quantity | 283883 trays/kits |
| Distribution | 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. |
| Initiated | 2026-06-25 |
| Classified | 2026-09-04 |
| Recall number | Z-3115-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — C.R. Bard Inc (Z-3115-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98840/
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