Draeger, Inc.: 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)

Hazard

Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.

Details from the source

Reason for recall: Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts. 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, T Quantity: 2050 units Lot/code info: Model/Catalog Number: MP01860; UDI Number: 04048675420699; Lot numbers: All lot numbers;

UPC codes

04048675420699

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.