Draeger ErgoStar CM 55 airway connectors recalled for cracked hoses
Draeger's ErgoStar CM 55 airway connectors (Model MP01855) have developed cracks in the hose under use. These connectors deliver oxygen and other gases to mechanically ventilated patients. The defect affects all lot numbers of this device worldwide.
From the FDA notice · Read the official notice ↗ · All Draeger recalls
What to do
- Stop using the ErgoStar CM 55 (Model MP01855) immediately
- Contact Draeger or your medical supplier for instructions on replacement or repair
- Report any patient injuries or safety concerns to the FDA
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- ErgoStar CM 55, Model/Catalog Number: MP01855, 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
This recall covers 4 products — see all of them.
Details
- Units affected
- 118850 units
- Illnesses reported
- None reported
- Manufactured in
- 3135 Quarry Rd, N/A, Telford, PA, United States
- Classification
- Class I
- Recall number
- Z-0592-2026
In the FDA's words
- Description
- ErgoStar CM 55, Model/Catalog Number: MP01855, 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: MP01855; UDI Number: 04048675420705; 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: 118850 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…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… (this page)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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