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
Flowonix Medical is recalling Physician Order Forms (PL-15400-00, Nov. 2018) used with Prometra programmable infusion pumps. The text may be misinterpreted as allowing reuse of the same drug solution before an MRI, which could cause infection.
The form contains text that could be misread as instructing to reuse the same drug solution extracted from the pump before an MRI procedure. This might lead to using contaminated medication, potentially causing infection.
Healthcare providers using the recalled Physician Order Forms with Prometra programmable infusion pumps are affected. Patients receiving treatments using these forms may be at risk of infection if the text is misinterpreted.
Check for Physician Order Form (PL-15400-00) from November 2018 used with Prometra Programmable Infusion Pumps (models 11827, 13827, or 16827).
Identify if your Physician Order Form (PL-15400-00) was distributed in November 2018 with Prometra programmable infusion pumps.
The form's text may be misinterpreted as allowing reuse of the same drug solution before an MRI, creating a possible infection risk.
Prometra Programmable 20mL Pump (model 11827), Prometra II Programmable 20mL Pump (model 13827), and Prometra II Programmable 40mL Pump (model 16827).
Check if your form matches the recalled version; no specific action is required beyond verifying the details.
We’ve drafted a message you can send Flowonix Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1996-2021 — Flowonix Medical Flowonix Medical Hello, I own a Flowonix Medical that is covered by recall Z-1996-2021 from Flowonix Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
