Terumo Advanced Perfusion System 1-Level Sensor II Gel Pads Product Usage: Level sensor pads are used to attach the level sensors to a hard shell reservoir. includes coupling gel.
Check against the official notice below — it lists the full affected range.
Terumo Cardiovascular Systems Corporation has voluntarily recalled Level Sensor II Gel Pads used to attach level sensors to hard shell reservoirs in their Advanced Perfusion System. The recall was initiated because the product expiration date labeling is displayed in a format that may not be recognizable to all users, making it non-compliant with labeling requirements. The affected products include 3,794 units with catalog number 217390 and lot numbers ranging from 782300 through 817488, manufactured between November 19, 2015 and November 25, 2016, and distributed between November 23, 2015 and December 15, 2016.
The recalled gel pads were distributed worldwide, including throughout the United States and to numerous countries including Canada, Mexico, Australia, Japan, China, India, and others across Asia, Europe, and South America. The source document does not specify what consumers or healthcare facilities should do with recalled products or how to obtain a remedy.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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: 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 Quantity: 3,794 Lot/code info: Level Sensor II Gel Pads, Catalog No. 217390, UDI No: 00886799000519, Lot Numers Ranging from 782300 through 817488, Manufactured from 19-Nov-2015 to 25-Nov-2016; Distributed from 23-Nov-2015 through 15-Dec-2016.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.