Medley System with Bar Code Module, Model 8600

• • Ongoing Z-1645-2026 FDA Class II ·initiated 11 Feb 2026

  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

• • Terminated Z-0534-2014 FDA Class I ·initiated 5 Dec 2013

  CareFusion is recalling the Alaris PC unit (model 8000 and 8015) because the Alaris PC unit will produce an audible alarm and the Alaris PC unit will display a System Error message.

510(k) Number

K041241 ↗

FDA Product Code

FRN

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Variable Pressure Syringe Pump

  Class II

  FDA 510(k) K974332 Active Cleared 29 Dec 1998

• Medley Syringe Pump Module System, Model 8110 Open recall

  Class II

  FDA 510(k) K023264 Active Cleared 19 Dec 2002

• A-Line Aep Monitor

  Class II

  FDA 510(k) K010965 Active Cleared 27 Jun 2001

• Medley ETCO2 Module (Includes Accessories), Model 8300

  Class II

  FDA 510(k) K031741 Active Cleared 9 Feb 2004

• Medley SPO2 Module, Model 8210 & SPO2 Sensors & Cable

  Class II

  FDA 510(k) K022677 Active Cleared 11 Sep 2002

• Alaris Medical Infusion System Administration Sets Open recall

  Class II

  FDA 510(k) K022209 Active Cleared 6 Aug 2002

See all devices from Alaris Medical Systems, Inc. →