Draeger, Inc.: ErgoStar CM 60, Model/Catalog Number: MP01860, Airway connector for conduction of respiratory gases between the breathing system and
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Draeger, Inc.
- Product
- 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.
- Reason / hazard
- Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
- Classification
- Class I
- Status
- Ongoing
- Distribution / sold at
- 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.
- Recall initiated
- 2025-11-10
- Code info
- Model/Catalog Number: MP01860; UDI Number: 04048675420699; Lot numbers: All lot numbers;
- Product quantity
- 2050 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Telford
- State
- PA
- Country
- United States
- Event id
- 97923
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