Lower riskMedical device recall · FDA · Published May 26, 2021
Flowonix Medical Physician Order Form Recall: Misinterpreted Text Risk
Flowonix Medical recalls PL-15400-00 Nov 2018 Physician Order Forms used with Prometra pumps due to risk of infection from misinterpreted text about drug reuse.
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
Take action
Contact the company
📍Recalling firmFlowonix Medical Inc120 Forbes Blvd Ste 170 · Mansfield, MA 02048-1150
“Flowonix Medical Physician Order Form Recall: Misinterpreted Text Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62485-flowonix-medical-physician-order-form-recall-misinterpreted-text-risk. Based on FDA recall #Z-1996-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1996-2021%22&limit=1).
The FDA announced on May 26, 2021, that Flowonix Medical Inc voluntarily recalled the Physician Order Form (PL-15400-00, Nov. 2018) distributed with Prometra Programmable Infusion Pump Systems due to a possible risk of infection. The agency classified the recall as Class II.
How to tell if you have it
Brand: Flowonix Medical
Product: Physician Order Form (PL-15400-00, Nov. 2018)
Compatible Pump Models: Prometra Programmable 20mL Pump (Catalog No. US Model), Prometra II Programmable 20mL Pump (Catalog No. 13827), Prometra II Programmable 40mL Pump (Catalog No. 16827)
The Physician Order Form may be misinterpreted as instructing users to reuse the same drug solution extracted from the pump prior to an MRI procedure, creating a possible risk of infection. The text 'Refill the pump and program refill with the same medication removed prior to MRI' is the source of this potential confusion.
Context
GovInfoNow's records show Flowonix Medical Inc has issued two other recalls since March 21, 2019, including a Dec. 24, 2019 recall for Prometra Programmable 20mL Pumps due to alarm function anomalies and a March 21, 2019 recall for Prometra II Pumps regarding unexpected shutdown risks. Other recent recalls of similar products include B Braun Medical Blood Set Recall (Oct. 29, 2025), B Braun Medical Outlook IV Set Recall (Oct. 29, 2025), and Medline Medical Kits Recall (March 24, 2026).
How to tell if you have this one
Check for Physician Order Form (PL-15400-00) from November 2018 used with Prometra Programmable Infusion Pumps (models 11827, 13827, or 16827).
Brand
Flowonix Medical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Form Details
Identify if your Physician Order Form (PL-15400-00) was distributed in November 2018 with Prometra programmable infusion pumps.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.7 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1996-2021 (May 26, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1996-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.