CLASS II Device recall · Reported 19 Jul 2017 · FDA Enforcement Report

ArjoHuntleigh Flowtron ACS900, medical pump recalled

Arjo is recalling ArjoHuntleigh Flowtron ACS900, medical pump, distributed nationwide in the US. The recall was initiated on 14 Jun 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel numbers: 526000-01, 526000-01P, 526000-02, 526000-02P. Serial numbers range from 1400028031 to 1600048470.

Quantity recalled40,675 units worldwide

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2714-2017
FDA event ID: 77551
Recalling firm: Arjo, Addison, IL
Classification: Class II
Status: Terminated
Recall initiated: 14 Jun 2017
FDA classified: 11 Jul 2017
Reported: 19 Jul 2017
Type: Voluntary: Firm initiated
Reason category: Device Malfunction
Device type: Medical Software

Timeline

14 Jun 2017	Recall initiated by company
11 Jul 2017	Classified by FDA	+27 days
19 Jul 2017	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was 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, 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.

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Arjo

All 9

Reported	Class	Recall	Company	Reason	Where
20 Apr 2016Device	CLASS II	The Concerto Basic Shower Trolley is intended recalled by Arjo	Arjo	Other	36 states
22 Oct 2014Device	CLASS II	Medium 2-Hooks Spreader Bar for use with Loop Slings recalled by Arjo	Arjo	Other	5 states
14 Aug 2013Device	CLASS II	Enterprise 9000 Bed recalled by Arjo	Arjo	Device Malfunction	Nationwide
14 Aug 2013Device	CLASS II	Enterprise 8000 Bed recalled by Arjo	Arjo	Other	Nationwide
2 Jan 2013Device	CLASS II	Flowtron Trio DVT Pump recalled by Arjo	Arjo	Other	Nationwide

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