# FDA recall Z-2961-2020

> **Terumo Cardiovascular Systems Corporation** · Class II · device recall initiated 2020-08-25.

## 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 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.

## Distribution

Worldwide distribution - US Nationwide distribution.

## Key facts

- **Recall number:** Z-2961-2020
- **Recalling firm:** Terumo Cardiovascular Systems Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-08-25
- **Report date:** 2020-09-23
- **Termination date:** 2021-01-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Ann Arbor, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2961-2020

## Citation

> AI Analytics. FDA recall Z-2961-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2961-2020. Source: US FDA. Licensed CC0.

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