Recall Z-2961-2020— Terumo Cardiovascular Systems Corporation
Class II · Terminated
Class II FDA medical device recall by Terumo Cardiovascular Systems Corporation, initiated 2020-08-25, terminated 2021-01-29. It names one FDA 510(k) clearance: K172220. Product: Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x3/32, Catalog Number 5791 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the line during extracorporeal procedures.. Reason: 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..
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-08-25
- Terminated
- 2021-01-29
- Firm location
- Ann Arbor, MI, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x3/32, Catalog Number 5791 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the line during extracorporeal procedures.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.