Reported Jun 12, 2019 · Terminated
Prometra Clinician Programmer (Touchscreen) Software version 2.00.29, Cat. No. 12828, used with Prometra and Prometra…
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 Clinician Programmer (Touchscreen) Software version 2.00.29, Cat. No. 12828, used with Prometra and Prometra II Programmable Pumps. For intrathecal infusion.
- Lot codes and dates
- Serial Numbers
318 of 318 codes
A15E0017A15J0019A16D0004RA17B0003RA17I0001RA18B0008RA18D0046RA18G0074RA18J0074A15E0023A15J0035A16D0013RA17B0004RA17I0002RA18B0009RA18D0047RA18G0079RA18J0077A15E0032A15J0038A16D0015RA17B0007RA17I0003RA18B0012RA18D0048RA18G0080RA18J0078A15H0003A15J0047A16D0018RA17C0001RA17I0004RA18B0014RA18D0052RA18J0001RA18J0081A15H0007A15J0050A16D0026RA17C0005RA17I0005RA18B0016RA18D0053RA18J0002RA18J050A15H0031A15J0051A16D0032RA17C0006RA17I0007RA18B0018RA18G0004RA18J0003RA18K0003A15H0038A15K0018A16D0033RA17C0007RA17I0008RA18B0020
- Serial Numbers
- Amount recalled
- 318
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.
This product could cause temporary or reversible health problems — stop using it.
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