ClearanceBrief
Recall Z-1645-2026 ยท FRN Pump, Infusion

CareFusion 303, Inc.

BD Alaris" System with Guardrails" Suite MX with Point of Care Unit

DateMar 26, 2026 (initiated Feb 11, 2026)
StatusOpen, Classified
ReasonDue 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
Root causeUnder Investigation by firm
ActionOn 02/11/2026, the firm sent via US Postal mail, an "URGENT MEDICAL DEVICE PRODUCT CORRECTION" letter to customers informing them that labeling does not indicate which Transport Layer Security (TLS) versions must be enabled on the hospital network to ensure secure Wi-Fi communication with the Alaris and BD Alaris Point-of-Care Unit (PCU) when using enterprise-level Wi-Fi security. Without clear labeling, hospitals may unknowingly disable TLS 1.0, resulting in network connectivity failure and memory leaks which could lead to potential System Error. Customers/clinicians are instructed to: 1. En
Quantity1,025,567
DistributionWorldwide 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
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K023264MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110
Alaris Medical Systems, Inc., Dec 19, 2002
K041241MEDLEY SYSTEM WITH BAR CODE MODULE, MODEL 8600
Alaris Medical Systems, Inc., Jul 6, 2004
K051641ALARIS SYSTEM PC UNIT, MODEL 8001
Cardinal Health, Alaris Products, Oct 20, 2005
K072105ALARIS SYSTEM WITH MMS, MODEL 8XXX
Cardinal Health 303,Inc., Dec 28, 2007
K133532ALARIS SYSTEM WITH GUARDRAILS SUITE MX
Carefusion 303, Inc., Aug 21, 2014
K211218BD Alaris System with Guardrails Suite MX v12.1.2
Carefusion 303, Inc., Jul 21, 2023