ErgoStar CM 45, Model/Catalog Number: MP01845, 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.
- Company
- Draeger, Inc.
- Recall Initiated
- November 10, 2025
- Posted
- December 8, 2025
- Recall Number
- Z-0591-2026
- Quantity
- 191470 units
- Firm Location
- Telford, PA
Reason for Recall
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
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.
Lot / Code Info
Model/Catalog Number: MP01845; UDI Number: 04048675420729; Lot numbers: All lot numbers;
Root Cause
Under Investigation by firm
Action Taken
On November 10, 2025, Urgent Medical Device Recall letters were sent to customers. Necessary Action: Identify if you have any affected product. Do not use any unused ErgoStar CM 40/CM 45/CM 55/CM 60 in your stock. Unused stock should be removed and returned to Draeger. Draeger recommends the alternative product MP01850 ErgoStar CM 50 as a suitable replacement. Please ensure that all potential users in your facility are made aware of this Urgent Medical Device Recall Notice and the information contained herein. If you have forwarded affected products to third parties, please also forward this Urgent Medical Device Recall notification.