United StatesErgoStar CM 40, CM 45, CM 55, and CM 60 airway connectors (Model/Catalog MP01840, MP01845, MP01855, MP01860; UDI numbers 04048675420736, 04048675420729, 04048675420705, 04048675420699) used to conduct respiratory gases between the breathing system and the patient interface are being recalled. The recall was issued after multiple complaints that cracks formed in the hose of specific catheter mounts.
What's being recalled
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.
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.
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.
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.
Recalling firm: Draeger, Inc., Telford, PA, United States.
How to identify it
Model/Catalog Number: MP01840; UDI Number:04048675420736; Lot numbers: All lot numbers Model/Catalog Number: MP01845; UDI Number: 04048675420729; Lot numbers: All lot numbers; Model/Catalog Number: MP01855; UDI Number: 04048675420705; Lot numbers: All lot numbers; Model/Catalog Number: MP01860; UDI Number: 04048675420699; Lot numbers: All lot numbers;
The hazard
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
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.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)