Reported Jun 12, 2019 · Terminated
Prometra Programmable Pump, Cat. No. 11827 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 Programmable Pump, Cat. No. 11827 For intrathecal infusion.
- Lot codes and dates
- Serial Numbers
788 of 788 codes
10AX4A0310BY4A4010EY4A3510GX4A8310HW4A3110HY4C1110JW4A2810KW4A4210KX4A4810AX4A0410BY4A4110EY4A3610GX4A8410HW4A4510HY4C1210JW4A2910KW4A4310KX4A4910AX4A0610BY4A4210EY4A3710GX4A8510HW4A5710HY4C1310JW4A3010KW4A4410KX4A5010AX4A1010BY4A4410EY4A3810GX4A8610HY4A7710HY4C1510JW4A3110KW4A4510KX4A5210AX4A1210BY4A4510EY4A4010GX4A8710HY4A7810HY4C1610JW4A3210KW4A4610KX4A5610AX4A1410BY4A4610EY4A4110GX4A8810HY4A7910HY4C1710JW4A3310KW4A4710KX4A5710AX4A2110BY4A4710EY4A4310GX4A8910HY4A8010HY4C18
- Serial Numbers
- Amount recalled
- 809
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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