FDA Device recall Z-1716-2019
Prometra II Programmable Pump (Clinical), Cat
- FDA Device
- Class II
- terminated
- Published 2019-06-12
On 2019-06-12 the FDA classified a Class II recall of Prometra II Programmable Pump (Clinical), Cat by Flowonix Medical, citing the pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout, is triggered. There has been an increase of Error 115 occurrences due to a softwa….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1716-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-03-21 |
| Published | 2019-06-12 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Flowonix Medical |
| Distribution | US |
Product
Prometra II Programmable Pump (Clinical), Cat. No. 01827 For intrathecal infusion.
Reason
The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout, is triggered. There has been an increase of Error 115 occurrences due to a software defect caused by a Healthcare Provider using a Clinician Programmer, Software Version 2.00.29, to program a Bridge or Demand bolus while the pump is set to either a Periodic Flow or Multiple Rates flow mode. Error 115 can also occur if dendrites form or if the pump is dropped.
Identifiers
| code_info | Serial Numbers: 10ET4A02 36AR4A11 36AR4A33 36FR4A01 36HS4A25 36JN4A09 36JN4A30 36KN4A13 36KN4A33 10ET4A06…Serial Numbers: 10ET4A02 36AR4A11 36AR4A33 36FR4A01 36HS4A25 36JN4A09 36JN4A30 36KN4A13 36KN4A33 10ET4A06 36AR4A12 36AR4A34 36FR4A08 36HS4A26 36JN4A10 36JN4A31 36KN4A15 36KN4A34 10ET4A07 36AR4A13 36AR4A35 36FR4A09 36HS4A27 36JN4A11 36JN4A32 36KN4A16 36KN4A35 10ET4A20 36AR4A14 36AR4A37 36FR4A12 36HS4A29 36JN4A12 36JN4A33 36KN4A17 36KN4A36 10ET4A21 36AR4A15 36BS4A08 36FR4A13 36HS4A34 36JN4A13 36JN4A35 36KN4A18 36KN4A38 10ET4A46 36AR4A16 36BS4A17 36FR4A16 36HS4A39 36JN4A14 36JN4A37 36KN4A19 36KN4A40 10IT4A16 36AR4A17 36BS4A18 36FR4A19 36HS4A42 36JN4A15 36JN4A39 36KN4A20 36KN4A41 10IT4A21 36AR4A18 36ES4A03 36FR4A22 36HS4A43 36JN4A16 36KN4A01 36KN4A21 36KN4A42 10IT4A22 36AR4A19 36ES4A07 36FR4A24 36HS4A46 36JN4A17 36KN4A02 36KN4A22 36KN4A43 36AR4A01 36AR4A20 36ES4A08 36HS4A01 36HS4A51 36JN4A18 36KN4A03 36KN4A23 36KN4A44 36AR4A02 36AR4A21 36ES4A14 36HS4A02 36HS4A53 36JN4A19 36KN4A04 36KN4A24 3 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1716-2019%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.