Z-1458-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 22, 2017
- Initiation Date
- February 20, 2017
- Termination Date
- June 1, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 208,560
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.
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
Code Information
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.