SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS - 71XX

• • Terminated Z-1484-06 FDA Unclassified (pre-2012) ·initiated 10 Aug 2006

  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.

510(k) Number

K032147 ↗

FDA Product Code

FRN

Models / Variants

70XX

71XX

72XX

7XXXX Series

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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• Medley Syringe Pump Module System, Model 8110 Open recall

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  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

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  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. →