FDA Device recall Z-1715-2019
Prometra II Programmable Pump, 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, 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-1715-2019 |
| 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, Cat. No. 13827 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: 10AA4A01X 10BC4A84X 10CC4C06X 10EB4A27X 10GB4A05X 10HA4E28X 10IA4B69X 10JA4B52X 10KB4A76X 1…Serial Numbers: 10AA4A01X 10BC4A84X 10CC4C06X 10EB4A27X 10GB4A05X 10HA4E28X 10IA4B69X 10JA4B52X 10KB4A76X 10AA4A02X 10BC4A86X 10CC4C07X 10EB4A28X 10GB4A07X 10HA4E29X 10IA4B70X 10JA4B53X 10KB4A77X 10AA4A03X 10BC4A87X 10CC4C08X 10EB4A29X 10GB4A08X 10HA4E30X 10IA4B71X 10JA4B54X 10KB4A78X 10AA4A04X 10BC4A88X 10CC4C09X 10EB4A30X 10GB4A10X 10HA4E31X 10IA4B72X 10JA4B55X 10KB4A79X 10AA4A05X 10BC4A89X 10CC4C10X 10EB4A31X 10GB4A11X 10HB4A01X 10IA4B73X 10JA4B56X 10KB4A80X 10AA4A06X 10BC4A90X 10CC4C11X 10EB4A33X 10GB4A13X 10HB4A02X 10IA4B74X 10JA4B57X 10KB4A81X 10AA4A07X 10BC4A92X 10CC4C12X 10EB4A34X 10GB4A14X 10HB4A03X 10IA4B75X 10JA4B58X 10KB4A82X 10AA4A08X 10BC4A94X 10CC4C13X 10EB4A35X 10GB4A15X 10HB4A04X 10IA4B76X 10JA4B59X 10KB4A84X 10AA4A09X 10BC4A96X 10CC4C14X 10EB4A36X 10GB4A17X 10HB4A05X 10IB4A31X 10JA4B60X 10KB4A86X 10AA4A10X 10BC4A97X 10CC4C15X 10EB4A39X 10GB4A18X 10HB4A06X 10IB4A32X 10JA4B61X 10 |
|---|
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-1715-2019%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.