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Capiox RX Hollow Fiber Oxygenator with Hardshell Reservoir recallZ-1345-2023 · Terumo Cardiovascular Systems Corporation · initiated Mar 1, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Terumo Cardiovascular Systems Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Process control

What the company is doing

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]

Recall details

Recall number
Z-1345-2023
Status
Open, Classified
Initiated by the company
Mar 1, 2023
Posted by the FDA
Apr 5, 2023
Recalling firm
Terumo Cardiovascular Systems Corporation
Quantity
1412 units
Product code
DTZ
FDA submissions
K062381
Distribution
US Nationwide. Belgium, Canada, Costa Rica, Thailand.

Product description

CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30

Code information (models, lots, serial numbers)

UDI-DI: (01)00699753450134; Lot Number: 2M10

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 91775).

Sources and updates

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