Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Physician Order Form (PL-15400-00 Recalled by Flowonix Medical Inc Due to Physician Order Form (PL-15400-00 Nov 2018) distributed is...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Flowonix Medical Inc directly.
Affected Products
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
Quantity: N/A
Why Was This 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
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Flowonix Medical Inc
Flowonix Medical Inc has 12 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report