Draeger ErgoStar CM 40 airway connectors recalled for cracked hoses
Draeger's ErgoStar CM 40 airway connectors (model MP01840) have developed cracks in the hose during use. This connector is used in breathing systems for mechanically ventilated patients. Multiple complaints have been reported worldwide, and all lot numbers are affected.
From the FDA notice · Read the official notice ↗ · All Draeger recalls
What to do
- Stop using the Draeger ErgoStar CM 40 (model MP01840) immediately if you have one
- Check your facility's inventory for affected units using lot number information
- Contact Draeger for replacement or guidance on safe alternatives
- Report any patient incidents or equipment failures to your biomedical team and the FDA
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- ErgoStar CM 40 Model/Catalog Number: MP01840 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.
- Sold in
- 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.
- Made for
- All ages (0 months and older)
This recall covers 4 products — see all of them.
Details
- Units affected
- 14420 units
- Illnesses reported
- None reported
- Manufactured in
- 3135 Quarry Rd, N/A, Telford, PA, United States
- Classification
- Class I
- Recall number
- Z-0590-2026
In the FDA's words
- Description
- ErgoStar CM 40 Model/Catalog Number: MP01840 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. Model/Catalog Number: MP01840; UDI Number:04048675420736; Lot numbers: All lot numbers 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. Affected quantity: 14420 units
- Hazard
- Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
4 products in this recall
The agency lists each product separately. Check every one you might have.
- ErgoStar CM 40 Model/Catalog Number: MP01840 Airway connector for conduction of respiratory gases between the breathing system and the patient interfac… (this page)Z-0590-2026 · 14420 units
- ErgoStar CM 45, Model/Catalog Number: MP01845, Airway connector for conduction of respiratory gases between the breathing system and the patient inter…Z-0591-2026 · 191470 units
- ErgoStar CM 55, Model/Catalog Number: MP01855, Airway connector for conduction of respiratory gases between the breathing system and the patient inte…Z-0592-2026 · 118850 units
- ErgoStar CM 60, Model/Catalog Number: MP01860, Airway connector for conduction of respiratory gases between the breathing system and the patient inte…Z-0593-2026 · 2050 units
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