Z-2960-2020 Class II Terminated
FDA device recall Z-2960-2020 was initiated by Terumo Cardiovascular Systems Corporation on August 25, 2020 and is designated Class II. 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 co… The recall status is terminated (terminated January 29, 2021). Affected quantity: 3.
Recall Details
- Product Type
- Devices
- Report Date
- September 23, 2020
- Initiation Date
- August 25, 2020
- Termination Date
- January 29, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3
Product 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 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 Pattern
Worldwide distribution - US Nationwide distribution.
Code Information
UDI: 00886799000045; Serial Numbers: 20230 20263 20265