Device recall: Prometra Clinician Programmer (Touchscreen) Software version 2.00.29, Cat. No. 12828, used with Prometra and Prometra…
Class II FDA enforcement event 82586. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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…
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Flowonix Medical Inc started this device recall on 21 Mar 2019. The firm address in the FDA record is in Mansfield, MA. FDA put the recall in Class II. FDA event 82586 has 5 product records. The first FDA enforcement report date is 12 Jun 2019. The record gives the status Terminated, with the termination date 5 Jun 2020.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
US nationwide distribution.
Recalling firm
Flowonix Medical Inc, Mansfield, MA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
5 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1712-2019 | Prometra Clinician Programmer (Touchscreen) Software version 2.00.29, Cat. No. 12828, used with Prometra and Prometra II Programmable Pumps. For intrathecal infusion. | 318 | Class II | Terminated | 12 Jun 2019 |
| Z-1713-2019 | Prometra Programmer (Grand Prime) Software version 2.00.29, Cat. No. 13828, used with Prometra and Prometra II Programmable Pumps. For intrathecal infusion. | 40 | Class II | Terminated | 12 Jun 2019 |
| Z-1714-2019 | Prometra Programmable Pump, Cat. No. 11827 For intrathecal infusion. | 809 | Class II | Terminated | 12 Jun 2019 |
| Z-1715-2019 | Prometra II Programmable Pump, Cat. No. 13827 For intrathecal infusion. | 6445 | Class II | Terminated | 12 Jun 2019 |
| Z-1716-2019 | Prometra II Programmable Pump (Clinical), Cat. No. 01827 For intrathecal infusion. | 163 | Class II | Terminated | 12 Jun 2019 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2019
- 968
- Share of these events in Class II
- 88%
- Product records in this event
- 5Median of the firm: 5
- Events of the firm on the register
- 4
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 26 May 2021 | Physician Order Form (PL-15400-00, Nov. 2018) distributed to end user used with the following: Prometra Programmable Inf | Device | Class II | 1 |
| 24 Dec 2019 | Prometra Programmable 20mL Pump. Catalog No. 11827 The device is an implantable infusion pump. GTIN-14 00810335020082 | Device | Class II | 6 |
| 22 May 2017 | PROMETRA II Programmable Infusion Pump, Implantable Infusion Pump, Catalog Number/REF 13827, Part Number PL-31790-02. Ma | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-1712-2019The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 82586. https://recallregister.com/fda/ii/82586/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
US nationwide distribution.
- What quantity of product is in FDA event 82586?
- The event has 5 product records. The first record gives this quantity:
318
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2019 have the same class?
- 88% of the 968 device events that started in 2019 are in Class II.