# FDA recall Z-1996-2021

> **Flowonix Medical Inc** · Class II · device recall initiated 2021-05-26.

## Product

Physician Order Form (PL-15400-00, Nov. 2018) distributed to end user used with the following:  Prometra Programmable Infusion Pump System:   MODEL/CATALOG #(s):   Catalog No.	US Model 	                                                  GTIN-14    11827 	Prometra Programmable 20mL Pump	      00810335020082    13827 	Prometra II Programmable 20mLPump 	00810335020228    16827	Prometra II Programmable 40mLPump	00810335020242

## Reason for recall

Physician Order Form (PL-15400-00 Nov 2018)    distributed is discontinued due to the text 'Refill the pump and program refill with the same medication removed prior to MRI' may be misinterpreted as 'reuse the same drug solution extracted from the pump prior to the MRI procedure', creating a possible risk of infection

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1996-2021
- **Recalling firm:** Flowonix Medical Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-05-26
- **Report date:** 2021-07-07
- **Termination date:** 2024-02-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mansfield, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1996-2021

## Citation

> AI Analytics. FDA recall Z-1996-2021. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/Z-1996-2021. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*