Home / Recalls / Carefusion 211 Inc dba Carefusion / Z-1889-2016

Z-1889-2016 Class I Terminated

Recalled by Carefusion 211 Inc dba Carefusion — Yorba Linda, CA

FDA device recall Z-1889-2016 was initiated by Carefusion 211 Inc dba Carefusion on May 17, 2016 and is designated Class I. Reason for recall: 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… The recall status is terminated (terminated September 28, 2017). Affected quantity: 922 units total (501 units in US).

Recall Details

Product Type: Devices
Report Date: June 22, 2016
Initiation Date: May 17, 2016
Termination Date: September 28, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 922 units total (501 units in US)

Product Description

AVEA Standard ventilator, 17311-xx (xx = 0 - 14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.

Reason for Recall

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).

Distribution Pattern

Worldwide Distribution - US (Nationwide) and the countries of Australia, Hungary, Paraguay, Belgium, Indonesia, Philippines, Bolivia, Ireland, Poland, Bermuda, India, Saudi Arabia, Canada, Japan, Singapore, Chile, Jordon, South Africa, China, Kuwait, Taiwan, Ecuador, Malaysia, Thailand, Egypt, Mexico, Turkey, France, Netherlands, United Kingdom, Guatemala, and Nicaragua.

Other recalls by Carefusion 211 Inc dba Carefusion

Z-1898-2016 Class I — AVEA GDE/UIM upgrade kit, 12283-PMN A continuous ventilator intended to mechani (May 17, 2016)
Z-1888-2016 Class I — AVEA Comprehensive ventilator, 17310-xx (xx = 0 - 14) A continuous ventilator (May 17, 2016)
Z-1892-2016 Class I — AVEA Standard ventilator-refurbished, R17311-xx (xx = 0-14) A continuous ventil (May 17, 2016)
Z-1897-2016 Class I — Gas Delivery Engine (GDE)-refurbished, R16650A A continuous ventilator intended (May 17, 2016)
Z-1895-2016 Class I — Gas Delivery Engine (GDE)-1st Generation, 16222-001-99 A continuous ventilator (May 17, 2016)
Z-1896-2016 Class I — Gas Delivery Engine (GDE), 16650A A continuous ventilator intended to mechanica (May 17, 2016)
Z-1899-2016 Class I — AVEA GDE upgrade kit, 12284-PMN A continuous ventilator intended to mechanicall (May 17, 2016)
Z-1890-2016 Class I — AVEA Standard with Compressor ventilator, 17312-xx (xx = 0 - 14) A continuous (May 17, 2016)
Z-1891-2016 Class I — AVEA Comprehensive ventilator-refurbished, R17310-xx (xx = 0-14) A continuous (May 17, 2016)
Z-1893-2016 Class I — AVEA Standard with Compressor ventilator-refurbished, R17312-xx (xx = 0-14) A c (May 17, 2016)