Flowonix Medical Inc recalls Physician Order Form (PL-15400-00, Nov. 2018) distributed to end user used with the following: Prometra Programmable In…

Recall date

May 26, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1996-2021

FDA classification

Class II

Brand / firm

Flowonix Medical Inc

Sold / distributed

US Nationwide distribution.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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