# FDA recall Z-2740-2017

> **Flowonix Medical, Inc.** · Class II · device recall initiated 2017-05-22.

## Product

PROMETRA II Programmable Infusion Pump, Implantable Infusion Pump, Catalog Number/REF 13827, Part Number PL-31790-02.  Manufactured by: Flowonix Medical Inc.,  --- The correction involves the labeling of the device plus the following Prometra II pump labeling is also being revised:  Intrathecal Catheter IFU, REF 11823, PL-22790-02;  Catheter Revision Kit IFU, REF 11 830, PL-21798-02; Refill Kit IFU, REF 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).

## Reason for recall

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.

## Distribution

Nationwide Distribution

## Key facts

- **Recall number:** Z-2740-2017
- **Recalling firm:** Flowonix Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-05-22
- **Report date:** 2017-07-26
- **Termination date:** 2018-06-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mount Olive, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2740-2017

## Citation

> AI Analytics. FDA recall Z-2740-2017. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2740-2017. Source: US FDA. Licensed CC0.

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