Recall MonitorHealth Products
ErgoStar CM 45 and ErgoStar CM 55
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Anaesthesiology
Product: ErgoStar CM 45 and ErgoStar CM 55
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| ErgoStar CM 45 | More than 10 numbers, contact manufacturer. | MP01845-XX |
| ErgoStar CM 55 | More than 10 numbers, contact manufacturer. | MP01855-XX |
Issue
The action is being initiated due to a potential issue with the smoothbore hoses of the catheter mounts. Under stress, these hoses could tear, potentially resulting in leakage. If leakage occurs, the ability of ventilators or anesthesia devices to compensate depends on the size of the leak and the ventilation pressure settings. In cases where compensation is not possible, ventilation may be restricted, posing a risk of desaturation or hypoxia for the patient.