Flowonix US Clinical 20mL Programmable Pump Recall for Firmware Alarm Defect
Flowonix Medical Inc is recalling US Clinical 20mL Programmable Pumps because a firmware anomaly may prevent the device from sending error codes or audible alarms during valve system issues.
What this means for you
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 is classified as FDA Class II. The hazard involves a failure of safety alarms in an implantable medical device, which poses a risk of harm if valve system issues go undetected, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Flowonix Medical Inc is recalling the US Clinical 20mL Programmable Pump (Catalog No. 01827, GTIN-14 00810335020082). The recall involves 6,670 units distributed domestically in the United States and internationally to the United Kingdom, Republic of Ireland, Poland, Greece, Italy, Germany, Netherlands, and Belgium. The affected devices are implantable infusion pumps with pump firmware version 0.26 manufactured from 2012 until the present time.
The recall is due to a pump alarm function anomaly in the firmware code. This defect may result in the pump not sending expected error code notifications to the Programmer or failing to emit an audible alarm tone in certain "out of tolerance" conditions associated with the pump's valve system. The source text does not report any specific illnesses, injuries, or deaths associated with this defect.
Healthcare providers and patients should contact Flowonix Medical Inc for further instructions regarding the recall and potential corrective actions. The specific serial numbers affected are listed in the agency's recall documentation.
The recalled product
- Product
- US Clinical 20mL Programmable Pump. Catalog No. 01827 The device is an implantable infusion pump. GTIN-14 00810335020082
- Manufacturer
- Flowonix Medical Inc
- Affected units
- 6,670
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Flowonix Medical Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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