Terumo recalls Flowmeter Module (accessory for Advanced Perfusion System 1) due to inaccurate flow readings that may not be easily detected during setup or use. Affected units have specific serial numbers.
Inaccurrate flow readings. Depending on the degree of inaccuracy, this issue may not be easy for the user to detect during setup or use (for example, following a Flow Probe relocation or manipulation).
Terumo is recalling Flowmeter Modules used with their Advanced Perfusion System 1 because they can give inaccurate flow readings. This may lead to errors in medical procedures that aren't easy to spot during setup or use.
The Flowmeter Module may provide inaccurate flow readings, especially after moving the flow probe. Users might not notice these errors during setup or use, which could lead to medical procedure errors.
Medical professionals using Terumo Advanced Perfusion System 1 devices are likely affected. Those with specific serial numbers listed in the recall are at risk of inaccurate readings.
Check if your Flowmeter Module has a serial number starting with 01662, 01672, 01680, 01681, 01682, 01683, or 01687. These units were sold with the Terumo Advanced Perfusion System 1.
Verify your Flowmeter Module's serial number to see if it matches the affected numbers: 01662, 01672, 01680, 01681, 01682, 01683, or 01687.
The Flowmeter Module provides the interface between the flow sensor and the Terumo Advanced Perfusion System 1.
Affected serial numbers are 01662, 01672, 01680, 01681, 01682, 01683, and 01687.
The recall record does not mention a remedy or fix.
We’ve drafted a message you can send Terumo to request your refund or repair — edit it as you like.
Subject: Recall Z-1478-2018 — Terumo Terumo Hello, I own a Terumo that is covered by recall Z-1478-2018 from Terumo. 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.
