ArjoHuntleigh Flowtron ACS900 Medical Pump Recalled for Deflation Failure
Arjo, Inc. is recalling 40,675 Flowtron ACS900 medical pumps worldwide because the device may fail to deflate the calf garment as intended without triggering an alarm.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device failure that poses a risk of harm (continuous pressure without deflation) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Arjo, Inc. dba ArjoHuntleigh is recalling 40,675 units of the Flowtron ACS900 medical pump, software V1.099, worldwide. The affected devices are used in professional healthcare facilities to prevent Deep Vein Thrombosis (DVT) in at-risk patients. The recall covers model numbers 526000-01, 526000-01P, 526000-02, and 526000-02P with serial numbers ranging from 1400028031 to 1600048470.
The recall is being issued due to reports of device failure where the pump delivers continuous pressure to the calf garment and does not deflate as intended. In these instances, the device does not trigger an alarm to alert medical staff to the malfunction. The devices are distributed in the United States and internationally to numerous countries including the United Kingdom, Australia, Canada, and Germany.
Healthcare facilities should stop using the affected devices and contact Arjo, Inc. for instructions on how to return or replace them. The device is intended for use only under the supervision of trained medical or clinical staff as part of a prescribed plan of care.
The recalled product
- 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.…
- Manufacturer
- Arjo, Inc. dba ArjoHuntleigh
- Affected units
- 40,675
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Model numbers: 526000-01
- 526000-01P
- 526000-02
- 526000-02P. Serial numbers range from 1400028031 to 1600048470.
Distribution
Distributed nationwide across the United States.
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