# FDA recall Z-2714-2017

> **Arjo, Inc. dba ArjoHuntleigh** · Class II · device recall initiated 2017-06-14.

## Product

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

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.

## Key facts

- **Recall number:** Z-2714-2017
- **Recalling firm:** Arjo, Inc. dba ArjoHuntleigh
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-06-14
- **Report date:** 2017-07-19
- **Termination date:** 2022-08-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Addison, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2714-2017

## Citation

> AI Analytics. FDA recall Z-2714-2017. Retrieved 2026-07-17 from https://api.ai-analytics.org/recall/Z-2714-2017. Source: US FDA. Licensed CC0.

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