Medley Pca Module, Model 8120

• • Terminated Z-0323-2018 FDA Class II ·initiated 17 Nov 2017

  The syringe plunger grippers may fail to automatically close around the syringe plunger press when the gripper control knob has been closed.

• • Terminated Z-1794-2009 FDA Unclassified (pre-2012) ·initiated 12 Jun 2009 ·via K032233, on the same 510(k)

  There is a potential risk of IUI connector failure in the Alaris System when these connectors become corroded or contaminated, which may result in an interruption of infusion with an audible and visual alarm. IUI connectors can become corroded or contaminated when exposed to fluid spills or improper cleaning. This notification is to reinforce the importance of inspection of IUI connectors prior

• • Terminated Z-1237-2009 FDA Unclassified (pre-2012) ·initiated 4 Mar 2009 ·via K032233, on the same 510(k)

  The Alaris PCA module can potentially infuse above or below the intended infusion dose.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K032233 ↗

FDA Product Code

MEA

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

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