Reported Jul 26, 2017 · Terminated
PROMETRA II Programmable Infusion Pump, Implantable Infusion Pump, Catalog Number/REF 13827, Part Number PL-31790-02.…
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. · 500 International Dr Ste 200 · Mount Olive, NJ · 07828-1381
Is this the product you have?
3 of 3 products
| Model / number | Product as published |
|---|---|
11823 | PL-22790-02; Catheter Revision Kit IFU, REF 11 830, PL-21798-02 |
| — | Refill Kit IFU |
11825 | PL-21794-00; Prometra II Patient Implant Card (Permanent) PL-32300-01; Prometra II Patient Implant Card (Temporary): PL-32375-01; Prometra II Patient Guide: PL-31912-01. The Prometra Programmable Infusion Pump System is indicated for intrathecal infusion of Infumorph (preservative-free morphine sulfate sterile solution) or preservative-free sterile 0.9% saline solution (sodium chloride injection, USP). |
- Lot codes and dates
- All
- Amount recalled
- US: 2204 units
Where it was sold
- Nationwide
Why it was recalled
Flowonix Medical received a report of a patient implanted with the Prometra II Programmable Pump who may have received a fatal drug overdose during an MRI procedure. The Prometra II pump has an FDA-approved design feature intended to permit safe exposure to an MRI without removing drug from the reservoir.
This product could cause temporary or reversible health problems — stop using it.
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