Class II — CareFusion 303, Inc.
| Recalling firm | CareFusion 303, INC. |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Due to product labeling not indicating which Transport Layer Security (TLS) version that must be enabled on hospital network to ensure secure Wi-Fi communication with Point-of-Care Units |
| Product | BD Alaris" System with Guardrails" Suite MX with Point of Care Unit |
| Quantity | 1,025,567 |
| Distribution | Worldwide distribution: U.S.(Nationwide) to states of: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MP. MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY O.U.S. (foreign) to countries of: Australia, Belgium, Bahrain, Botswana, Canada, China, Cuba, Germany, India, Israel, Italy, Japa… |
| Initiated | 2026-02-11 |
| Classified | 2026-03-26 |
| Recall number | Z-1645-2026 |
| 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 — CareFusion 303, Inc. (Z-1645-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98250/
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