—#184501

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.

FDA product code: DTZ — Oxygenator, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K151791
Affected lot / code info: (1) Lot Number: YD16 (2) Lot Number: YD23 Unit GTIN Code: (01)00699753450837

Why it was recalled

Capiox FX25 Advance oxygenator may be the incorrect configuration (East vs. West)

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

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

Recalling firm

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

Distribution

Distribution pattern: US Nationwide Foreign: Belgium, India

Timeline

Recall initiated: 2020-11-11
Terminated: 2021-11-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #184501. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.