Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog # 801188, UDI 00886799000588 The electronic gas blender provides control and monitoring of the gas flow rate and oxygen content of the gas input to the oxygenator in the perfusion circuit.

The gas flow rate output of the EPGS may be inaccurate due to a defect in the internal flowmeter.

The firm, Terumo, sent an "URGENT MEDICAL DEVICE RECALL" letter dated April 18, 2019 to its customers. The letter described the product, problem and actions to be taken. The Customers were instructed to take the following actions: 1. Review this Medical Device Recall notice. 2. Assure that all users have received notice of this issue, and prominently display this notice where all users may access it. 3. Continue use of the device in conjunction with the backup external mechanical flowmeter found in the Terumo System 1 Accessory Kit. 4. Confirm receipt of this communication by completing and returning the attached Customer Response Form as indicated on the form. 5. Terumo CVS will contact users to schedule the field correction activities. Note: Terumo CVS recommends that users continue using their Terumo System 1 with EGPS, with the required backup external mechanical flowmeter, while waiting for this correction. Customers with questions are directed to the following: Terumo CVS Customer Service: 1.800.521.2818 Monday - Friday 8 a.m. to 6 p.m. ET Recall Fax: 1.734.741.6149