|
A recall has been issued for the Fisher and Paykel Healthcare, Ltd., Infant Nasal CPAP Prongs. Fisher and Paykel Healthcare received 24 reports in which the device has malfunctioned. There were zero injuries and zero deaths. The firm received reports of the affected prongs detaching from the nasal tubing during use, especially when mucous and/or moisture are present. When the affected prongs detach from the nasal tubing, therapy is likely to be interrupted. This may cause low blood oxygen (hypoxemia). The detached prongs may enter an infant’s mouth and present a potential risk of choking and airway obstruction. The use of the affected product may cause serious adverse health consequences, including death. For more information, please see http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm398631.htm
| This email was sent to list-fda@xxxxxxxxxxx using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 |
 |
|
