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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model numbers: 526000-01, 526000-01P, 526000-02, 526000-02P. Serial numbers range from 1400028031 to 1600048470.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Arjo, Inc. dba ArjoHuntleigh
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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.
Product Codes/Lot Numbers:
Model numbers: 526000-01, 526000-01P, 526000-02, 526000-02P. Serial numbers range from 1400028031 to 1600048470.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2714-2017
Related Recalls
Reports of the bolts connecting the stretcher to the hydraulic piston and the stretcher tilting mechanism becoming loose.
The upper portion of the hooks on the spreader bar are too flexible for holding the loops of the sling. The loop of the sling could potentially come out of the hooks if positioned in the upper portion of the hooks.
ArjoHuntleigh has received reports of unintended movement where the backrest and/or thigh sections of the bed have moved without anyone consciously pressing the control button. These incidents have occurred in High Dependency and Intensive Therapy environments where unintended movement of the patient may have serious consequences.