—#198830

Product

CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE

FDA product code: DTZ — Oxygenator, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K180950
Affected lot / code info: UDI-DI: (01)00699753450868; Lot Number AM03

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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 4439935738@efax.com Terumo Recall Email: TCVSCustomerResponseElkton@terumomedical.com

Recalling firm

Firm: Terumo Cardiovascular Systems Corporation
Address: 125 Blue Ball Rd, Elkton, Maryland 21921-5315

Distribution

Distribution pattern: US Nationwide. Belgium, Canada, Costa Rica, Thailand.

Timeline

Recall initiated: 2023-03-01
Posted by FDA: 2023-04-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #198830. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.