FDA Device recall Z-1121-2020
Prometra II 20mL Pump
- FDA Device
- Class II
- ongoing
- Published 2020-02-19
On 2020-02-19 the FDA classified a Class II recall of Prometra II 20mL Pump by Flowonix Medical, citing 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 to….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1121-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-12-24 |
| Published | 2020-02-19 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Flowonix Medical |
| Distribution | US |
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.
Identifiers
| code_info | All units with pump firmware version 0.26 manufactured from 2012 until the present time. Serial Numbers 10HW4A31 1…All units with pump firmware version 0.26 manufactured from 2012 until the present time. Serial Numbers 10HW4A31 10AZ4A69X 10AZ4A07X 10BZ4A16X 10BZ4A61X 10BZ4A41X 10AZ4A48X 10AZ4A50X 10AZ4A23X 10AZ4A36X 10AZ4A42X 10BZ4A37X 10BZ4A64X 10BZ4A12X 10CZ4B09X 10CZ4A95X 10CZ4B22X 10BZ4A18X 10CZ4A79X 10CZ4A86X 10CZ4A96X 10CZ4A88X 10CZ4A80X 10CZ4A85X 10CZ4A81X 10CZ4A82X 10CZ4A78X 10CZ4A91X 10CZ4A94X 10CZ4A90X 10CZ4A77X 10CZ4B28X 10CZ4B05X 10CZ4B15X 10CZ4B21X 10CZ4A87X 10CZ4B32X 10AZ4A41X 10CZ4B23X 10CZ4A93X 10CZ4B01X 10CZ4B17X 10CZ4B04X 10CZ4B30X 10BZ4A55X 10CZ4B08X 10CZ4A76X 10CZ4B33X 10CZ4B20X 10DZ4A01X 10DZ4A58X 10DZ4A19X 10CZ4B36X 10CZ4A84X 10DZ4A18X 10CZ4B24X 10DZ4A76X 10BZ4A30X 10CZ4B26X 10BZ4A09X 10DZ4A51X 10DZ4A93X 10DZ4A32X 10CZ4B03X 10DZ4A89X 10BZ4A11X 10DZ4A30X 10CZ4B25X 10DZ4A65X 10DZ4A05X 10DZ4A98X 10DZ4A08X 10DZ4A42X 10DZ4A77X 10CZ4A92X 10DZ4A35X 10DZ4A80X 10DZ4A92X 10DZ4A88X 10DZ4A07X 10BZ4A39X 10 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1121-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.