Reported Jun 12, 2019 · Terminated
Prometra II Programmable Pump (Clinical), Cat. No. 01827 For intrathecal infusion.
Flowonix Medical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Flowonix Medical Inc · 120 Forbes Blvd Ste 170 · Mansfield, MA · 02048-1150
Is this the product you have?
- Prometra II Programmable Pump (Clinical), Cat. No. 01827 For intrathecal infusion.
- Lot codes and dates
- Serial Numbers
163 of 163 codes
10ET4A0236AR4A1136AR4A3336FR4A0136HS4A2536JN4A0936JN4A3036KN4A1336KN4A3310ET4A0636AR4A1236AR4A3436FR4A0836HS4A2636JN4A1036JN4A3136KN4A1536KN4A3410ET4A0736AR4A1336AR4A3536FR4A0936HS4A2736JN4A1136JN4A3236KN4A1636KN4A3510ET4A2036AR4A1436AR4A3736FR4A1236HS4A2936JN4A1236JN4A3336KN4A1736KN4A3610ET4A2136AR4A1536BS4A0836FR4A1336HS4A3436JN4A1336JN4A3536KN4A1836KN4A3810ET4A4636AR4A1636BS4A1736FR4A1636HS4A3936JN4A1436JN4A3736KN4A1936KN4A4010IT4A1636AR4A1736BS4A1836FR4A1936HS4A4236JN4A15
- Serial Numbers
- Amount recalled
- 163
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
Why it was recalled
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 product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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