Recall Z-1347-2023— Terumo Cardiovascular Systems Corporation

Name: FDA recall Z-1347-2023
Creator: U.S. Food and Drug Administration
Published: 2023-03-01

Class II · Ongoing

Class II FDA medical device recall by Terumo Cardiovascular Systems Corporation, initiated 2023-03-01. It names one FDA 510(k) clearance: K151791. Product: CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC. Reason: Some Capiox NX, RX and FX Oxygenators may contain an arterial thermistor component that is improperly bonded to the oxygenator port. This may result in a leak at the point where the arterial thermistor is improperly bonded to the oxygenator port..

Recalling firm: Terumo Cardiovascular Systems Corporation
Classification: Class II
Status: Ongoing
Initiated: 2023-03-01
Firm location: Elkton, MD, United States

510(k) clearances named in this recall

1 on FDA's record

K151791 — Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Reservoir, Terumo Capiox FX25 Advance Oxygenator with Integrated Arterial Filter and ReservoirTerumo Cardiovascular Systems Corporation·cleared 2015-11-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC

Reason for recall

Some Capiox NX, RX and FX Oxygenators may contain an arterial thermistor component that is improperly bonded to the oxygenator port. This may result in a leak at the point where the arterial thermistor is improperly bonded to the oxygenator port.

Data sourced from openFDA. This site is unofficial and independent of the FDA.