Reported Jul 19, 2017 · Terminated
ArjoHuntleigh Flowtron ACS900, medical pump, software V1.099 Device is used to prevent the occurrence of Deep Vein…
Arjo, Inc. dba ArjoHuntleigh
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Arjo, Inc. dba ArjoHuntleigh · 2349 W Lake St · Addison, IL · 60101-6183
Is this the product you have?
- 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.
- Lot codes and dates
- Model numbers526000-01, 526000-01P, 526000-02, 526000-02P. Serial numbers range from 1400028031 to 1600048470
- Amount recalled
- 40,675 units worldwide
Where it was sold
- Nationwide
Why it was recalled
Reports of the device failure involving delivering continuous pressure to the calf garment and not deflating as intended, without triggering an alarm.
This product could cause temporary or reversible health problems — stop using it.
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