Alaris Medical Infusion System Administration Sets

• • Ongoing Z-3080-2026 FDA Class I ·initiated 19 Aug 2026

  Due to discrepancies in specific attributes in the performance data for infusion sets, which may lead to inappropriate pump performance.

• 2 recalls, same reason

  • Ongoing Z-0035-2026 FDA Class I ·initiated 11 Sep 2025
  • Ongoing Z-2180-2025 FDA Class I ·initiated 8 Jul 2025 ·on shared 510(k) K022209

  Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.

• • Ongoing Z-1944-2024 FDA Class II ·initiated 18 Apr 2024

  Due to infusion set tubing drip chamber becoming detached from the tubing potentially causing delays in treatment, or unintentionally exposing users to harsh infusates.

• 3 recalls, same reason

  • Ongoing Z-0351-2024 FDA Class II ·initiated 11 Oct 2023
  • Ongoing Z-0350-2024 FDA Class II ·initiated 11 Oct 2023
  • Ongoing Z-0349-2024 FDA Class II ·initiated 11 Oct 2023

  Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).

• • Terminated Z-1484-06 FDA Unclassified (pre-2012) ·initiated 10 Aug 2006 ·on shared 510(k) K022209

  This recall was initiated because of a potential for over infusion with all models of the Alaris SE Pumps (formerly the Signature Edition Infusion Pumps) caused by key bounce.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K022209 ↗

FDA Product Code

FPA

Device Class

Class II

Regulation

21 CFR Part 880.5440

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

• Medley Pca Module, Model 8120 Open recall

  Class II

  FDA 510(k) K043299 Active Cleared 10 Dec 2004

See all devices from Alaris Medical Systems, Inc. →