FDA Enforcement
Class II
Terminated
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.
Recall: Z-2960-2020
·
Reported September 23, 2020
Enforcement
- Recall Number
- Z-2960-2020
- Event ID
- 86338
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Terumo Cardiovascular Systems Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 23, 2020
- Initiation Date
- August 25, 2020
- Classification Date
- September 11, 2020
- Termination Date
- January 29, 2021
- Address
- 6200 Jackson Rd, N/A, Ann Arbor, MI, 48103-9586, United States
Description
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.
Code Info
UDI: 00886799000045; Serial Numbers: 20230 20263 20265
Distribution
Worldwide distribution - US Nationwide distribution.
Quantity
3