Infusion Pump Order Form Discontinued Due to Ambiguous Reuse Instructions
Flowonix Medical is recalling physician order forms for Prometra infusion pumps due to ambiguous wording that could be misinterpreted as instructions to reuse previously extracted medication, posing an infection risk.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II device with instruction ambiguity that creates risk of improper medication reuse and potential infection. While no illnesses have been reported, the hazard represents a serious risk-of-harm scenario meeting criteria for High severity.
Plain-English summary
Flowonix Medical Inc. is discontinuing the Physician Order Form (PL-15400-00, Nov. 2018) used with the Prometra Programmable Infusion Pump System. The form is distributed nationwide and applies to multiple pump models: the Prometra Programmable 20mL Pump (Catalog No. 11827), Prometra II Programmable 20mL Pump (Catalog No. 13827), and Prometra II Programmable 40mL Pump (Catalog No. 16827).
The form contains ambiguous instructions that state "Refill the pump and program refill with the same medication removed prior to MRI." Healthcare providers may misinterpret this language as an instruction to reuse the same drug solution that was previously extracted from the pump in preparation for an MRI procedure. Reusing extracted medication solution creates a possible risk of infection and does not align with proper medication handling protocols.
Healthcare facilities and physicians who use the Prometra infusion pump systems should discontinue use of the November 2018 version of the physician order form. Questions or concerns regarding this discontinuation should be directed to Flowonix Medical Inc.
The recalled product
- 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…
- Manufacturer
- Flowonix Medical Inc
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- All Physician Order Form (PL-15400-00
- Nov. 2018)
Distribution
Distributed nationwide across the United States.
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