Flowonix Medical Inc: Medical Device Recall in 2021 - (Recall #: Z-1996-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: May 26, 2021

Date Posted: July 7, 2021

Recall Number: Z-1996-2021

Event ID: 88044

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

Status: Terminated

Product Quantity: N/A

Code Information:

All Physician Order Form (PL-15400-00, Nov. 2018)

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated