Recall Z-1458-2017— Terumo Cardiovascular Systems Corporation

Name: FDA recall Z-1458-2017
Creator: U.S. Food and Drug Administration
Published: 2017-02-20

Class II · Terminated

Class II FDA medical device recall by Terumo Cardiovascular Systems Corporation, initiated 2017-02-20, terminated 2017-06-01. It names one FDA 510(k) clearance: K153376. Product: Terumo Advanced Perfusion System 1-Level Sensor II Pads, Product Usage: Ultrasonic couplant used to facilitate the transmission of sound energy between the level sensor and the reservoir.. Reason: Terumo CVS initiated a voluntary recall for the Level Sensor II Pads and Level Sensor Gel Pads due to non-compliant labeling because the product expiration date is displayed in a format that may not be recognizable to all users..

Recalling firm: Terumo Cardiovascular Systems Corporation
Classification: Class II
Status: Terminated
Initiated: 2017-02-20
Terminated: 2017-06-01
Firm location: Ann Arbor, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K153376 — Advanced Perfusion System 1Terumo Cardiovascular Systems Corporation·cleared 2015-12-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Terumo Advanced Perfusion System 1-Level Sensor II Pads, Product Usage: Ultrasonic couplant used to facilitate the transmission of sound energy between the level sensor and the reservoir.

Reason for recall

Terumo CVS initiated a voluntary recall for the Level Sensor II Pads and Level Sensor Gel Pads due to non-compliant labeling because the product expiration date is displayed in a format that may not be recognizable to all users.

Data sourced from openFDA. This site is unofficial and independent of the FDA.