Home / Recalls / Arjo, Inc. dba ArjoHuntleigh / Z-2714-2017

Z-2714-2017 Class II Terminated

Recalled by Arjo, Inc. dba ArjoHuntleigh — Addison, IL

FDA device recall Z-2714-2017 was initiated by Arjo, Inc. dba ArjoHuntleigh on June 14, 2017 and is designated Class II. Reason for recall: Reports of the device failure involving delivering continuous pressure to the calf garment and not deflating as intended, without triggering an alarm. The recall status is terminated (terminated August 12, 2022). Affected quantity: 40,675 units worldwide.

Recall Details

Product Type
Devices
Report Date
July 19, 2017
Initiation Date
June 14, 2017
Termination Date
August 12, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
40,675 units worldwide

Product Description

ArjoHuntleigh Flowtron ACS900, medical pump, software V1.099 Device is used to prevent the occurrence of Deep Vein Thrombosis (DVT) in at-risk patients. The system must be used as part of a prescribed plan of car under the supervision of trained medical and/or Clinical staff. The system is intended for use only in professional healthcare facilities. It is not intended to be used in the home healthcare environment.

Reason for Recall

Reports of the device failure involving delivering continuous pressure to the calf garment and not deflating as intended, without triggering an alarm.

Distribution Pattern

Worldwide Distribution - US (Nationwide) and internationally to the following countries: United Kingdom, Australia, New Zealand, Japan, Italy, United Arab Emirates, France, Canada, Brazil, Austria, Saudi Arabia, Qatar, India, Switzerland, Bahrain, Kuwait, South Africa, Lebanon, Netherlands, Poland, Spain, Ecuador, Hong-Kong, Colombia, Malaysia, Paraguay, Mauritius, Cyprus, Greece, Oman, Norway, Ireland, Pakistan, Czech Republic, Mexico, Sweden, Tanzania, Hungary, Singapore, Jordan, Israel, Denmark, Chile, and Germany.

Code Information

Model numbers: 526000-01, 526000-01P, 526000-02, 526000-02P. Serial numbers range from 1400028031 to 1600048470.

Other recalls by Arjo, Inc. dba ArjoHuntleigh

  • Z-1388-2016 Class II — The Concerto Basic Shower Trolley is intended for assisted hygiene care, especia (December 21, 2015)
  • Z-0079-2015 Class II — Medium 2-Hooks Spreader Bar for use with Loop Slings, sizes small, medium and la (January 21, 2013)
  • Z-0615-2013 Class II — Flowtron Trio DVT Pump; an Rx intermittent pneumatic compression deep vein throm (December 10, 2012)
  • Z-0476-2013 Class II — Enterprise 8000 Bed; an AC-powered adjustable hospital bed; ArjoHuntleigh AB, Es (November 16, 2012)
  • Z-0477-2013 Class II — Enterprise 9000 Bed; an AC-powered adjustable hospital bed with built-in electro (November 16, 2012)
  • Z-1949-2012 Class II — Sara Plus Mobile Patient Lifter; manufactured for Arjo by Medibo Medical Product (June 29, 2012)
  • Z-1947-2012 Class II — Encore Mobile Patient Lifter; manufactured by Arjo Ltd., St. Catherine Street, G (June 29, 2012)
  • Z-1948-2012 Class II — Chorus Mobile Patient Lifter; manufactured by Arjo Ltd., St. Catherine Street, G (June 29, 2012)

FDA data resources