ArjoHuntleigh Flowtron ACS900 recall
ArjoHuntleigh Flowtron ACS900, medical pump, software V1.099 Device is used to prevent the occurrence of Deep Vein Thrombosis (DVT) in at-risk…
Why was ArjoHuntleigh Flowtron ACS900 recalled?
Reports of the device failure involving delivering continuous pressure to the calf garment and not deflating as intended, without triggering an alarm.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model numbers: 526000-01, 526000-01P, 526000-02, 526000-02P. Serial numbers range from 1400028031 to 1600048470.
- Product
- ArjoHuntleigh Flowtron ACS900, medical pump, software V1.099 Device is used to prevent the occurrence of Deep Vein Thrombosis (DVT) in at-risk…
- Recalling firm
- Arjo, Inc. dba ArjoHuntleigh
- Quantity
- 40,675 units worldwide
- 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.
- Recall date
- July 19, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)