|
|
The U.S. Food and Drug Administration is aware that CooperSurgical has issued a letter to affected customers recommending certain ventilator be removed from where they are used or sold.
CooperSurgical stated that units from specific lots of the INCA Neonatal Nasal CPAP Complete Set and Replacement Set may exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use. If the loose connection is not detected during assembly and/or placement, the tubing may leak at the connection to the nasal cannula or disconnect from the nasal cannula. This can result in loss of CPAP pressure, which may reduce the effectiveness of treatment and lead to decreased oxygenation of the patient until connection is restored.
As of August 11, CooperSurgical has reported no serious injuries or deaths associated with this issue.
CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact the CooperSurgical Recall Support Team at fieldaction@coopersurgical.com or call (203) 895-2789.
|
|
|
|
