Arjo, Inc. dba ArjoHuntleigh recalls ArjoHuntleigh Flowtron ACS900, medical pump, software V1.099 Device is used to prevent the occurrence of Deep Vein Thro…

Recall date

June 14, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2714-2017

FDA classification

Class II

Brand / firm

Arjo, Inc. dba ArjoHuntleigh

Sold / distributed

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,…

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.