Terumo recalls air sensors for extracorporeal procedures due to wiring causing false alarms. Check serial numbers 20019-20020 for affected units.
Internal testing at the supplier, revealed that a crimped wire was placed into an air bubble detector (ABD) sensor connector backwards, preventing the crimped wire from locking into the mating wire connector. This intermittent connection may result in false air bubble alarms.
Terumo is recalling a specific air sensor used in heart-lung machines because a wiring issue causes false alarms during surgery. This could lead to unnecessary pauses in critical procedures if the alarm is triggered incorrectly.
The sensor's wiring is connected backward, causing intermittent connections that trigger false air bubble alarms. This may pause critical procedures unnecessarily but does not cause physical harm to patients or staff.
Healthcare professionals using Terumo and Sarns air detection systems for extracorp: 1. Patients undergoing heart-lung procedures with this sensor. 2. Staff handling the sensor during surgery.
Check for serial numbers 20019 or 20020 on the sensor. The product is used with Terumo and Sarns air detection systems during heart-lung procedures.
Look for serial numbers 20019 or 20020 on the sensor.
Internal testing found the wiring was connected backward, causing false air bubble alarms during surgery.
No serious injury risk; false alarms may pause procedures but do not cause physical harm.
Check for serial numbers 20019 or 20020 on the sensor used with Terumo and Sarns air detection systems.
We’ve drafted a message you can send Terumo to request your refund or repair — edit it as you like.
Subject: Recall Z-2961-2020 — Terumo Terumo Hello, I own a Terumo that is covered by recall Z-2961-2020 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.