Z-2714-2017 Class II Terminated
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.