Reported Sep 23, 2020 · Terminated
Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x3/32, Catalog Number 5791 - Product Usage: intended for…
Terumo Cardiovascular Systems Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Terumo Cardiovascular Systems Corporation · 6200 Jackson Rd · Ann Arbor, MI · 48103-9586
Is this the product you have?
- Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x3/32
- Catalog Number 5791 - Product Usageintended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the line during extracorporeal procedures
- Lot codes and dates
- UDI00886799000052
- Serial Numbers20019 20020
- Amount recalled
- 2
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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