Recall Z-1121-2020— Flowonix Medical Inc
Class II · Ongoing
Class II FDA medical device recall by Flowonix Medical Inc, initiated 2019-12-24. FDA's recall record names no specific 510(k) clearance for this event. Product: Prometra II 20mL Pump. Catalog No. 13827 The device is an implantable infusion pump. GTIN-14 00810335020228. Reason: A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm tone in certain "out of tolerance" conditions associated with the pump's valve system..
- Recalling firm
- Flowonix Medical Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2019-12-24
- Firm location
- Mansfield, MA, United States
Product description
Prometra II 20mL Pump. Catalog No. 13827 The device is an implantable infusion pump. GTIN-14 00810335020228
Reason for recall
A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm tone in certain "out of tolerance" conditions associated with the pump's valve system.
Data sourced from openFDA. This site is unofficial and independent of the FDA.