ArjoHuntleigh Flowtron ACS900, medical pump, software V1.099 Device is used to prevent the occur...
FDA Device Recall #Z-2714-2017 — Class II — June 14, 2017
Recall Summary
| Recall Number | Z-2714-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 14, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Arjo, Inc. dba ArjoHuntleigh |
| Location | Addison, IL |
| Product Type | Devices |
| 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.
Lot / Code Information
Model numbers: 526000-01, 526000-01P, 526000-02, 526000-02P. Serial numbers range from 1400028031 to 1600048470.
Other Recalls from Arjo, Inc. dba ArjoHuntleigh
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1388-2016 | Class II | The Concerto Basic Shower Trolley is intended f... | Dec 21, 2015 |
| Z-0079-2015 | Class II | Medium 2-Hooks Spreader Bar for use with Loop S... | Jan 21, 2013 |
| Z-0615-2013 | Class II | Flowtron Trio DVT Pump; an Rx intermittent pneu... | Dec 10, 2012 |
| Z-0476-2013 | Class II | Enterprise 8000 Bed; an AC-powered adjustable h... | Nov 16, 2012 |
| Z-0477-2013 | Class II | Enterprise 9000 Bed; an AC-powered adjustable h... | Nov 16, 2012 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.