|
|
Catheter Mount Recall: Draeger Removes ErgoStar Catheter Mounts
The FDA is aware that Draeger has issued a letter to affected customers recommending certain ErgoStar Catheter Mounts be removed from where they are used or sold. Draeger has become aware of cases in which cracks have formed in the hose of specific ErgoStar catheter mounts. If these cracks form during use, leakage will occur. Depending on the size of the leakage and the selected ventilation pressure, the ventilator/anesthesia device can compensate for this. If the leakage cannot be compensated for, ventilation is restricted and may lead to desaturation or hypoxia for the patient.
This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as a Class I recall, the most serious type. This device may cause serious injury or death if you continue to use it without correction.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Draeger Customer Service at US-Medical@draeger.com or 1-800-437-2437 (press 2 at the prompt, then 1).
|
|
|
|
