CareFusion 303, Inc.
Device Recalls (Class II)
Class II
Z-1645-2026
·
20260401
·
Ongoing
Product
BD Alaris" System with Guardrails" Suite MX with Point of Care Unit
Reason for Recall
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
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, ...
Source: openFDA Enforcement API