Draeger ErgoStar CM 60 catheter mount recalled for cracked hose
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.
From the FDA notice · Read the official notice ↗ · All Draeger recalls
What to do
- 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.
Is yours affected?
Compare your label or packaging with the recalled product.
- 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.
- 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
- 2050 units
- Illnesses reported
- None reported
- Manufactured in
- 3135 Quarry Rd, N/A, Telford, PA, United States
- Classification
- Class I
- Recall number
- Z-0593-2026
In the FDA's words
- Description
- 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. Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts. Model/Catalog Number: MP01860; UDI Number: 04048675420699; 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: 2050 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…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… (this page)Z-0593-2026 · 2050 units
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