ErgoStar CM 60 airway connectors recalled after cracks formed in the hose
Draeger is recalling 2,050 ErgoStar CM 60 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 60, model MP01860, 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 2,050 units carrying UDI 04048675420699, 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 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.
- Manufacturer
- Draeger, Inc.
- Affected units
- 2,050
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: MP01860
- UDI Number: 04048675420699
- Lot numbers: All lot numbers
Distribution
Part of a larger recall action
This product is one of 4 recalled by Draeger, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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