Z-1347-2023Class II

CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CXFX25REC, 3CXFX25RWC

Name: Z-1347-2023 CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC
Creator: Terumo Cardiovascular Systems Corporation
Published: 2023-03-01
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2023-03-01 / Open, Classified / root cause: manufacturing process

FDA source

Terumo Cardiovascular Systems Corporation began a recall of CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC on 2023-03-01. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1347-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-03-01
Posted: 2023-04-05
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC
Product code: DTZ Oxygenator, Cardiopulmonary Bypass
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: An URGENT MEDICAL DEVICE RECALL notification letter dated 3/1/23 was sent to customers. RECOMMENDED ACTIONS Terumo CVS advises users to remove all affected product from inventory and return unused product to Terumo CVS following the instructions provided in this notice. Terumo CVS will credit the user s accounts for returned, unused products. AFFECTED POPULATION The affected population is all patients on which an impacted Capiox NX, RX or FX Oxygenator is used. CUSTOMER INSTRUCTIONS - Review this Medical Device Recall notice and ensure that all users receive notice of this issue. Refer to the Customer Response Form to identify your product inventory that is subject to this action. Confirm receipt of this communication by completing and returning the attached Customer Response Form to the email address or fax number indicated on the form. Please return the Customer Response Form even if you no longer have the affected product in inventory. If the affected product has been distributed to another user or location, please forward a copy of the notice as needed. Terumo CVS will issue a Return Goods Authorization upon receipt of the Customer Response Form. Return all affected products to Terumo CVS. QUESTIONS? We encourage you to contact Terumo CVS with any questions or concerns: Terumo CVS Customer Service: 1.800.521.2818 Monday Friday, 8 a.m. 6 p.m. ET Terumo Recall Fax: 443-993-5738 or emailing [email protected] Terumo Recall Email: [email protected]
Quantity in commerce: 4940 units
Distribution: US Nationwide. Belgium, Canada, Costa Rica, Thailand.
Product codes and lots: UDI-DI: (01)00699753450868; Lot Number AM03

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1347-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1345-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-12	2023-04-05
Z-1346-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-12	2023-04-05
Z-1347-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-12	2023-04-05

Product code DTZ

K151791Class IITerumo 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

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)