Public recall detail

Capiox FX25 Hollow Fiber Oxygenator With Integrated Arterial Filter

2023-03-09

medium
Recall Safety notice
Quick summary

Quick summary: Capiox FX25 Hollow Fiber Oxygenator With Integrated Arterial Filter. Date: 2023-03-09.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Capiox FX25 Hollow Fiber Oxygenator With Integrated Arterial Filter. Date: 2023-03-09.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandTerumo Cardiovascular Systems Corporation
ProductCapiox FX25 Hollow Fiber Oxygenator With Integrated Arterial Filter
IssueMedical devices - Performance
Recall classType II
IdentificationRA-73122

Affected products

ProductCapiox FX25 Hollow Fiber Oxygenator With Integrated Arterial Filter
Lot2M10 2M03 AM03
Model3CX*FX25RWC 3CX*FX25REC
Serial number2M10 2M03 AM03
DescriptionCapiox FX25 Hollow Fiber Oxygenator With Integrated Arterial Filter

Issue

Terumo Cardiovascular Systems (Terumo CvS) has discovered that 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. Recall start date: February 24, 2023.

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Cardiovascular
CompaniesTerumo Cardiovascular Systems Corporation 125 Blue Ball Road, Elkton, Maryland, United States, 21921
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-73122
Background{}
CompaniesTerumo Cardiovascular Systems Corporation 125 Blue Ball Road, Elkton, Maryland, United States, 21921
AudiencesHealthcare
Source updated2023-03-09

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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