Class 2 Device Recall Capiox FX25 Advance Oxygenator

• Date Initiated by Firm: November 11, 2020
• Create Date: December 14, 2020
• Recall Status: Terminated on November 22, 2021
• Recall Number: Z-0565-2021
• Recall Event ID: 86779
• 510(K)Number: K151791
• Product Classification: Oxygenator, cardiopulmonary bypass - Product Code DTZ
• Product: (1) Capiox FX25 (West) Advance Oxygenator- with left port, 4-liter Reservoir, XC modified to Advance, Sterile; Catalog Number: 3CX*FX25RWC; ; (2) Capiox FX25 (East) Advance Oxygenator - FX25 with right port, 4-liter Reservoir, XC modified to Advance; Catalog Number: 3CX*FX25REC; ; CAPIOX FX25 Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir-intended to be used to exchange gases between blood and a gaseous environment during cardiopulmonary bypass surgery.
• Code Information: (1) Lot Number: YD16 (2) Lot Number: YD23 Unit GTIN Code: (01)00699753450837
• Recalling Firm/ Manufacturer: Terumo Cardiovascular Systems Corporation; 6200 Jackson Rd; Ann Arbor MI 48103-9586
• Manufacturer Reason for Recall: Capiox FX25 Advance oxygenator may be the incorrect configuration (East vs. West)
• FDA Determined Cause: Labeling mix-ups
• Action: Terumo issued URGENT Medical Device Removal letter on 11/11/2020 to all end users who have received potentially affected product via 2-day FedEx mailing. The letter states reason for recall, health risk and action to take: Remove of the Capiox FX25 Advance Reservoir/Oxygenator assembly from the cardboard box(es) but keep the unit within the sterile Tyvek pouch bag. " Review the label on the back of the reservoir to determine if the configuration is East or West. " Rotate the unit until the blood outlet port of the oxygenator is facing the observer (blood outlet port is evident by the red cap on the oxygenator port). With the blood outlet port facing the observer, locate the water ports on the end cap of the oxygenator. If the Water ports are facing to the left with the blood outlet port facing the observer, then the unit is an East configuration. If the Water ports are facing to the right with the blood outlet port facing the observer, then the unit is a West configuration (see photos below). " If you identify an incorrectly configured oxygenator, follow the instructions on the response form and contact Terumo CVS to return the device. CUSTOMER INSTRUCTIONS 1. Review this Medical Device Removal and the Recommended Actions and assure that all users receive notice of this issue. 2. Confirm receipt of this communication by completing and returning the attached Customer Response Form as indicated on the form regardless of whether affected product is currently in your facilitys possession or it has been consumed. 3. In the event the affected product has been further distributed, please forward a copy of this notification to the appropriate end user. 4. Respond to Terumo CVS by emailing or faxing the attached Customer Response Form to the email address or fax number indicated on the form. QUESTIONS? We encourage you to contact Terumo CVS with any questions or concerns: ¿ Terumo CVS Customer Service: 1.800.521.2818
• Quantity in Commerce: 5,079 Total: 523 US and 4,556 OUS
• Distribution: US Nationwide Foreign: Belgium, India
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DTZ and Original Applicant = TERUMO CARDIOVASCULAR SYSTEMS CORPORATION