|
|
Ventilator Correction: Breas Medical Updates Use Instructions for Vivo 45 LS due to Potential Risk of Elevated Formaldehyde Exposure in New Ventilators
Breas Medical is updating use instructions for Vivo 45 LS ventilators because internal testing of the ventilator identified the potential for a short-term increase in formaldehyde exposure for people using new ventilators for the first time.
The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall. This device may cause serious injury or death if you continue to use it.
Questions?
Customers in the U.S. with questions about this recall should contact their local service representative or Breas Medical Inc. service at 855-436-8724 ext. 110 or e-mail vivotechnicalsupport@breas.com.
|
|
|
|
