Z-1458-2017Class II

Terumo Advanced Perfusion System 1-Level Sensor II Pads

Name: Z-1458-2017 Terumo Advanced Perfusion System 1-Level Sensor II Pads
Creator: Terumo Cardiovascular Systems Corporation
Published: 2017-02-20
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2017-02-20 / Terminated / root cause: labeling and UDI

FDA source

Terumo Cardiovascular Systems Corporation began a recall of Terumo Advanced Perfusion System 1-Level Sensor II Pads, Product Usage: Ultrasonic couplant used to facilitate the transmission of sound energy between the... on 2017-02-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1458-2017
Classification: Class II
Status: Terminated
Initiated: 2017-02-20
Posted: 2017-03-14
Terminated: 2017-06-01
Recalling firm: Terumo Cardiovascular Systems Corporation
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.
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Terumo CVS initiated a voluntary recall by issuing a safety advisory for their Terumo Advanced Perfusion System 1-Level Sensor II Pads, and Terumo Advanced Perfusion System 1-Level Sensor II 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. Customers are asked to do the following: 1. Review the Safety Advisory. 2. Assure that all users receive notice of this issue. 3. Confirm receipt of this Safety Advisory by emailing or faxing the attached Customer Response Form to the email address or fax number indicated on the form. For questions contact Terumo CVS at 1-800-521-2818, Monday Friday, 8 a.m. 6 p.m. ET. Any adverse events experienced with the use of this product, and/or quality problems should also be reported to the FDAs MedWatch Program: Phone: 1.800.FDA.1088 Fax: 1.800.FDA.0178, Web: www.fda.gov/medwatch/report.htm MedWatch Online Voluntary Reporting Form (mail to address on form): www.fda.gov/Safety/MedWatch/HowtoReport
Quantity in commerce: 208,560
Distribution: Worldwide Distribution - US Nationwide in the states of: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, WV and the countries of: Mexico, AUSTRALIA, UNITED ARAB EMIRATES (UAE), Indonesia, Singapore, Taiwan, Thailand, COLOMBIA, CHILE, Vietnam, India, China, Malaysia, BELGIUM, Japan, CANADA
Product codes and lots: Level Sensor II Pads, Catalog No. 195240, UDI No: 10886799001704, Lot Numers Ranging from 782300 through 817488, Manufactured from 20-Nov2015 to 25-Nov-2016; Distributed from 23-Nov-2015 through 15-Dec-2016.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1458-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1458-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-22	2017-03-13
Z-1459-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-22	2017-03-13

Product code DTQ

K153376Class IIAdvanced Perfusion System 1Terumo Cardiovascular Systems Corporation / cleared 2015-12-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)