FDA-Device2025-12-17Class IPROCESSING DEFECT
Draeger ErgoStar CM 45 airway connector recalled for cracking hose defect
What this means
Draeger's ErgoStar CM 45 airway connectors (Model MP01845) have developed cracks in the hose in certain units. These connectors are used to deliver breathing gases to patients on mechanical ventilators. The cracks could disrupt proper airflow during critical respiratory support.
- Stop using all Draeger ErgoStar CM 45 airway connectors (Model MP01845) immediately
- Contact Draeger customer support or your medical device supplier for instructions on inspection, replacement, or return
- Check your facility's inventory for affected lot numbers (all lots are affected)
The agency's original wording
Hazard
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
191470 units
Manufactured in
3135 Quarry Rd, N/A, Telford, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0591-2026Want us to check the next one for you?
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