—#153246

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.

FDA product code: DTQ — Console, Heart-Lung Machine, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K153376
Affected lot / code info: 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.

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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

Recalling firm

Firm: Terumo Cardiovascular Systems Corporation
Address: 6200 Jackson Rd, Ann Arbor, Michigan 48103-9586

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2017-02-20
Posted by FDA: 2017-03-14
Terminated: 2017-06-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #153246. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.