[Recalled] Prometra Programmable Pump, Cat. No. 11827 For intrathecal infusion. — The pump shuts down unexpectedly if Error 115, an alarm associated with a watch… | FDA 2019-03-21
This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.
Recall details
| Product | Prometra Programmable Pump, Cat. No. 11827 For intrathecal infusion. |
|---|---|
| Brand / manufacturer | Flowonix Medical Inc |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1714-2019 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 21 March 2019 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Flowonix Medical Inc
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.