Draeger ErgoStar CM 45 catheter mounts recalled for hose cracks
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.
From the FDA notice · Read the official notice ↗ · All Draeger recalls
What to do
- 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)
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- 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.
- 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 (under 100 years)
This recall covers 4 products — see all of them.
Details
- Units affected
- 191470 units
- Illnesses reported
- None reported
- Manufactured in
- 3135 Quarry Rd, N/A, Telford, PA, United States
- Classification
- Class I
- Recall number
- Z-0591-2026
In the FDA's words
- Description
- 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. Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts. Model/Catalog Number: MP01845; UDI Number: 04048675420729; 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: 191470 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… (this page)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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