Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x1/16 UAS… — Class II medical device recall Z-2960-2020
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2020-09-23, distributed nationwide. Internal testing at the supplier, revealed that a crimped wire was placed into an air bubble detector (ABD) se
| Recall number | Z-2960-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Terumo Cardiovascular Systems Corporation, Ann Arbor, MI, United States |
| Recall initiated | 2020-08-25 |
| Classified | 2020-09-11 |
| Reported by FDA | 2020-09-23 |
| Terminated | 2021-01-29 |
| Distributed | Nationwide (US) |
| Quantity | 3 |
| UPC / GTIN / UDI-DI | 00886799000045 |
| Serial numbers | 20230, 20263, 20265 |
| Model numbers | 5785 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2960-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.