CanadaErgoStar CM 45 (model MP01845-XX; serial/lot numbers with more than 10 digits) and ErgoStar CM 55 (model MP01855-XX; serial/lot numbers with more than 10 digits) are affected. They were recalled because the smoothbore hoses of the catheter mounts can tear under stress, causing leakage that may restrict ventilation and pose a risk of desaturation or hypoxia; contact the manufacturer for more information.
What's being recalled
Companies: Draegerwerk Ag & Co. Kgaa, Moislinger Allee 53-55, Lubeck, Germany, 23542.
How to identify it
Affected products: ErgoStar CM 45; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: MP01845-XX
Affected products: ErgoStar CM 55; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: MP01855-XX
The hazard
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.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)