FDAJune 14, 2017device

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 intend...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Reports of the device failure involving delivering continuous pressure to the calf garment and not deflating as intended, without triggering an alarm.

What to do

FDA enforcement status: Terminated

Brands named

arjo inc dba arjohuntleigharjoarjo inc

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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