Infant/Neonatal and Adult/Pediatric Filterline and Vitaline H sets, Airway Adapters, Ventline Set, and CO2 Sampling Line
Brand(s)
Last updated
Summary
Product
Infant/Neonatal and Adult/Pediatric Filterline and Vitaline H sets, Airway Adapters, Ventline Set, and CO2 Sampling Line
Issue
Medical devices - Labelling and packaging
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| Filterline Set | All lots. | XS04620 |
| Filterline H Set Infant/Neonatal | All lots. | 006324 |
| Omni Ventline Set | All lots. | 012495 |
| Filterline H Set | All lots. | XS04624 |
| Filterline H Set Adult/Pediatric | All lots. | 007737 010580 |
| Airway Adapter, Adult/Pediatric | All lots. | 010989 |
| CO2 Sampling Line | All lots. | 010991 |
| Filterline H Set Infant/Neonatal, Long | All lots. | 007738 |
| Filterline Set Long, Adult/Pediatric | All lots. | 010579 007768 |
| Vitaline H Set Adult/Pediatric | All lots. | 010787 |
| Vitaline H Set Infant/Neonatal | All lots. | 010807 |
Issue
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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Anaesthesiology
Companies
Oridion Medical 1987 Ltd.
7 Hamarpe St., Jerusalem, Israel, 9777407
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-77070
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