Reported Feb 19, 2020 · Ongoing
Prometra II 40mL Pump. Catalog No. 16827 The device is an implantable infusion pump. GTIN-14 00810335020242
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 40mL Pump. Catalog No. 16827 The device is an implantable infusion pump. GTIN-14 00810335020242
- Lot codes and dates
- All units with pump firmware version 0.26 manufactured from 2012 until the present time. Serial Numbers
10GC4A24X10GC4A02X10GC4A18X10GC4A22X10GC4A14X4MA00044X4MA00006X10GC4A12X10GC4A09X10GC4A06X10GC4A21X4MA00008X10GC4A01X10GC4A20X10GC4A11X10GC4A16X10GC4A17X4MA00045X4MA00055X10GC4A08X4MA00032X4MA00031X4MA00010X4MA00042X
- All units with pump firmware version 0.26 manufactured from 2012 until the present time. Serial Numbers
- Amount recalled
- 6670 (US)
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
Why it was recalled
A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm tone in certain "out of tolerance" conditions associated with the pump's valve system.
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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