Recall Z-2714-2017— Arjo, Inc. dba ArjoHuntleigh
Class II · Terminated
Class II FDA medical device recall by Arjo, Inc. dba ArjoHuntleigh, initiated 2017-06-14, terminated 2022-08-12. It names one FDA 510(k) clearance: K143438. 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. The system is intended for use only in professional healthcare facilities. It is not intended to be used in the home healthcare environment.. Reason: Reports of the device failure involving delivering continuous pressure to the calf garment and not deflating as intended, without triggering an alarm..
- Recalling firm
- Arjo, Inc. dba ArjoHuntleigh
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-06-14
- Terminated
- 2022-08-12
- Firm location
- Addison, IL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.