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FDA-Device2026-04-01Class IIMISBRANDING

BD Alaris System with Guardrails Suite MX recalled for missing Wi-Fi security labeling

CareFusion
FALSE CLAIMSNationwide distribution

Check BD Alaris System network security requirements

The labeling on BD Alaris System with Guardrails Suite MX does not specify which version of Transport Layer Security (TLS) must be enabled on hospital networks for secure Wi-Fi communication with Point-of-Care Units. This could create confusion during setup and potentially leave devices with inadequate security settings.

  • Contact BD (CareFusion) or your hospital IT department for the correct TLS version required for your system
  • Verify that your hospital network has the proper TLS version enabled before deploying or using affected units
  • Check the affected serial numbers listed in the recall to see if your system is included
Hazard

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

Sold states
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, Japan, Korea, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Pakistan, Philippines, Qatar, Saudi Arabia, Singapore, South Africa, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom.
Affected count
1,025,567
Manufactured in
10020 Pacific Mesa Blvd, San Diego, CA, United States
Products
BD Alaris" System with Guardrails" Suite MX with Point of Care Unit

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1645-2026

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