Reported Jun 12, 2019 · Terminated
Prometra II Programmable Pump, Cat. No. 13827 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, Cat. No. 13827 For intrathecal infusion.
- Lot codes and dates
- Serial Numbers
2,962 of 2,962 codes
10AA4A01X10BC4A84X10CC4C06X10EB4A27X10GB4A05X10HA4E28X10IA4B69X10JA4B52X10KB4A76X10AA4A02X10BC4A86X10CC4C07X10EB4A28X10GB4A07X10HA4E29X10IA4B70X10JA4B53X10KB4A77X10AA4A03X10BC4A87X10CC4C08X10EB4A29X10GB4A08X10HA4E30X10IA4B71X10JA4B54X10KB4A78X10AA4A04X10BC4A88X10CC4C09X10EB4A30X10GB4A10X10HA4E31X10IA4B72X10JA4B55X10KB4A79X10AA4A05X10BC4A89X10CC4C10X10EB4A31X10GB4A11X10HB4A01X10IA4B73X10JA4B56X10KB4A80X10AA4A06X10BC4A90X10CC4C11X10EB4A33X10GB4A13X10HB4A02X10IA4B74X10JA4B57X10KB4A81X10AA4A07X10BC4A92X10CC4C12X10EB4A34X10GB4A14X10HB4A03X
- Serial Numbers
- Amount recalled
- 6445
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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