Infant/Neonatal and Adult/Pediatric Filterline and Vitaline H sets, Airway Adapters, Ventline Set, and CO2 Sampling Line
Brand(s)
Summary
Contact the manufacturer if you require additional information.
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 |
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 |
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
Oridion Medical 1987 Ltd.
7 Hamarpe St., Jerusalem, Israel, 9777407
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