FDA Device recall Z-2960-2020
Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x1/16 UAS BLK, Catalog Number 5785 - Product Usage: intended for use with Terum…
- FDA Device
- Class II
- terminated
- Published 2020-09-23
On 2020-09-23 the FDA classified a Class II recall of Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x1/16 UAS BLK, Catalog Number 5785 - Product Usage: intended for use with Terum… by Terumo Cardiovascular Systems, citing 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 in….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2960-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-08-25 |
| Published | 2020-09-23 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Terumo Cardiovascular Systems |
| Distribution | US |
Product
Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x1/16 UAS BLK, Catalog Number 5785 - 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.
Identifiers
| code_info | UDI: 00886799000045; Serial Numbers: 20230 20263 20265 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
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All Terumo Cardiovascular Systems recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2960-2020%22
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