Ventilator airway connectors recalled after cracks formed in the hose
Draeger is recalling 191,470 ErgoStar CM 45 airway connectors after multiple complaints in which cracks formed in the hose of specific catheter mounts. The FDA has classified the action as Class I.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: Scored 5 because the FDA has classified this action as Class I, which the rubric maps directly to Critical.
Plain-English summary
The Draeger ErgoStar CM 45, model MP01845, is being recalled. The device is an airway connector for conduction of respiratory gases between the breathing system and the patient interface, such as an endotracheal tube mask, of a mechanically ventilated patient.
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
The recall covers 191,470 units carrying UDI 04048675420729, across all lot numbers. Distribution was worldwide, including California, Florida, Illinois, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas and Wisconsin domestically, and a wide range of other countries. The FDA has classified the action as Class I, its most serious category.
Facilities should quarantine affected stock immediately and follow Draeger's instructions.
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.
- Manufacturer
- Draeger, Inc.
- Hazard
- cracking
- airway-circuit
- ventilation
- class-i
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model/Catalog Number: MP01845
- UDI Number: 04048675420729
- Lot numbers: All lot numbers
Distribution
Distributed in 10 states:
- CA
- FL
- IL
- NY
- OH
- OK
- PA
- SC
- TX
- WI
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