Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Prometra II Programmable 20mL Pump. Catalog No. 93827 The device Recalled by Flowonix Medical Inc Due to A pump alarm function anomaly in the pump...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Flowonix Medical Inc directly.
Affected Products
Prometra II Programmable 20mL Pump. Catalog No. 93827 The device is an implantable infusion pump. GTIN-14 00810335020YYY (YYY= in-country language specific)
Quantity: 1083 (OUS)
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Flowonix Medical Inc
Flowonix Medical Inc has 12 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report