ErgoStar CM 60, Model/Catalog Number: MP01860, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient.
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
Advertisement
Recall Number
Z-0593-2026
Classification
Class I
Status
Ongoing
Category
device
Initiated
2025-11-10
Reported
2025-12-17
Distribution
Worldwide distribution. US states of CA, FL, IL, NY, OH, OK, PA, SC, TX, and WI; Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czech Republic, Ecuador, Finland, France, Germany, Hungary, Indonesia, Italy, Japan, Mexico, Netherlands, Norway, Pakistan, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovakia, South Africa, South Korea, Spain, Switzerland, Thailand, Turkiye, Ukraine, and United Kingdom.
Code Info
Model/Catalog Number: MP01860; UDI Number: 04048675420699; Lot numbers: All lot numbers;
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.