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Flowonix Medical Inc recalls Physician Order Form (PL-15400-00, Nov. 2018) distributed to end user used with the following: Prometra Programmable In
Recalled July 7, 2021 · FDA recall Z-1996-2021 · Flowonix Medical
Hazard
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 · FDA Class II
Units
N/A
Sold at
US Nationwide distribution.
Description
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
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
Manufacturer(s)
Flowonix Medical Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →