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Infant neonatal and adult pediatric filterline and vitaline h sets, airway adapters, ventline set, and co2 sampling line

Official notice

6 Mar 2025

Last checked

6 Mar 2025

Medium riskHealth Canada

An official Health Canada notice concerns Infant neonatal and adult pediatric filterline and vitaline h sets, airway adapters, ventline set, and co2 sampling line. Medtronic is issuing an update to Instruction For Use (IFU) following reports of difficulty or inability in disconnecting the adapter from patient's endotracheal tube to perform a procedure. As noted in the IFU, during setup, ensure that the airway adapter can be easily attached and detached from the breathing circuit/tubing before proceeding. Recall Start Date: February 19, 2025 Published 2025-03-06.

What to do now

Contact the manufacturer if you require additional information.

Recall number

77070

Official notice

2025-03-06

The hazard

Medtronic is issuing an update to Instruction For Use (IFU) following reports of difficulty or inability in disconnecting the adapter from patient's endotracheal tube to perform a procedure. As noted in the IFU, during setup, ensure that the airway adapter can be easily attached and detached from the breathing circuit/tubing before proceeding. Recall Start Date: February 19, 2025

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

77070

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Affected products

Product 1

Affected products - Filterline Set, Lot or serial number - All lots., Model or catalog number - XS04620

Product 2

Affected products - Filterline H Set Infant/Neonatal, Lot or serial number - All lots., Model or catalog number - 006324

Product 3

Affected products - Omni Ventline Set, Lot or serial number - All lots., Model or catalog number - 012495

Product 4

Affected products - Filterline H Set, Lot or serial number - All lots., Model or catalog number - XS04624

Product 5

Affected products - Filterline H Set Adult/Pediatric, Lot or serial number - All lots., Model or catalog number - 007737 010580

Product 6

Affected products - Airway Adapter, Adult/Pediatric, Lot or serial number - All lots., Model or catalog number - 010989

Product 7

Affected products - CO2 Sampling Line, Lot or serial number - All lots., Model or catalog number - 010991

Product 8

Affected products - Filterline H Set Infant/Neonatal, Long, Lot or serial number - All lots., Model or catalog number - 007738

Product 9

Affected products - Filterline Set Long, Adult/Pediatric, Lot or serial number - All lots., Model or catalog number - 010579 007768

Product 10

Affected products - Vitaline H Set Adult/Pediatric, Lot or serial number - All lots., Model or catalog number - 010787

Product 11

Affected products - Vitaline H Set Infant/Neonatal, Lot or serial number - All lots., Model or catalog number - 010807

Risk / hazard

Medtronic is issuing an update to Instruction For Use (IFU) following reports of difficulty or inability in disconnecting the adapter from patient's endotracheal tube to perform a procedure. As noted in the IFU, during setup, ensure that the airway adapter can be easily attached and detached from the breathing circuit/tubing before proceeding. Recall Start Date: February 19, 2025

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand: Oridion Medical 1987, Infant Neonatal And Adult Pediatric Filterline And Vitaline H Sets Airway Adapters Ventline Set And Co2 Sampling Line.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

77070

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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