FDA-Device2025-12-17Class IPROCESSING DEFECT
Draeger ErgoStar CM 60 airway connector recalled for cracking hose defect
Stop using Draeger ErgoStar CM 60 connectors
Draeger airway connectors (model MP01860) used in mechanical ventilation systems have developed cracks in the hose. These connectors deliver breathing gases to patients on ventilators. The cracks could potentially interrupt gas delivery.
- If you use Draeger ErgoStar CM 60 connectors (model MP01860) in a hospital or clinical setting, stop using them immediately.
- Contact Draeger, Inc. for instructions on replacement or repair.
- Check all lot numbers—all batches of this model are affected.
Hazard
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
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
2050 units
Manufactured in
3135 Quarry Rd, N/A, Telford, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0593-2026Don't want to check this manually?
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