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Avea 16044

by Carefusion GUDID

Withdrawn United States

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10846446001174 UDI-DIDate31 Mar 2017ListedStatusWithdrawn

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — GUDID listing Listed

Recalls

15 recalls · FDA

  • 12 recalls, same reason

    • Terminated Z-1894-2016 FDA Class I initiated 17 May 2016
    • Terminated Z-1888-2016 FDA Class I initiated 17 May 2016
    • Terminated Z-1892-2016 FDA Class I initiated 17 May 2016
    • Terminated Z-1897-2016 FDA Class I initiated 17 May 2016
    • Terminated Z-1895-2016 FDA Class I initiated 17 May 2016
    • Terminated Z-1896-2016 FDA Class I initiated 17 May 2016
    • Terminated Z-1898-2016 FDA Class I initiated 17 May 2016
    • Terminated Z-1899-2016 FDA Class I initiated 17 May 2016
    • Terminated Z-1889-2016 FDA Class I initiated 17 May 2016
    • Terminated Z-1890-2016 FDA Class I initiated 17 May 2016
    • Terminated Z-1893-2016 FDA Class I initiated 17 May 2016
    • Terminated Z-1891-2016 FDA Class I initiated 17 May 2016

    CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface Module (UIM).

    • Terminated Z-1609-2015 FDA Class I initiated 3 Apr 2015

    A pressure transducer failure can develop, activating a false Extended High Ppeak or Circuit Occlusion Alarm. The Safety Valve will open to ambient air and the unit will stop ventilating, allowing spontaneous breathing patients to breathe. The malfunction may delay initiation or cease ventilation. Nonbreathing patients will need manual ventilation or to be connected to another ventilator.

    • Terminated Z-2273-2013 FDA Class I initiated 5 Sep 2013

    CareFusion has identified a potential risk associated with AVEA ventilators when used at higher altitudes. A proactive complaint review identified an error in the barometric pressure compensation. CareFusion is voluntarily initiating a field correction of the affected devices to correct the error.

    • Terminated Z-0510-2012 FDA Unclassified (pre-2012) initiated 8 Sep 2011

    The recall was initiated because Carefusion has identified a potential risk associated with certain AVEA ventilators and affected replacement parts manufactured between March 1, 2009 and June 30, 2011. Carefusion is voluntarily initiating a field correction of the affected devices to preclude the possibility of this risk.

Specification

GUDID

Trade Name
Avea
Generic Name
Ventilator breathing circuit, single-use
Model / Reference
16044
Primary DI / UDI-DI
10846446001174
510(k) Number
FDA Product Code
CBK
GMDN Term
Ventilator breathing circuit, single-use
Device Class
Class II
Regulation Number
868.5895
Commercial Distribution
Not in Commercial Distribution

Related devices

Cleared under the same submission (K103211)

Show all (12)

Other devices from Carefusion

See all devices from Carefusion →

Properties

  • Prescription Use
  • Manufacturing Date

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No