Home / Recalls / Medical Devices
Vital Signs Colorado Inc. recalls Vital Signs Anesthesia Circuits The Ventilator Circuit is intended for use as an interface between a ventilator depen
Recalled January 29, 2014 · FDA recall Z-0812-2014 · Vital Signs Colorado
Hazard
A circuit in use was occluded by a blue port cap that was inadvertently attached to the circuit as a result of an internal inspection error and will cause occlusion of gas flow. · FDA Class II
Units
1,827,920 units US , 504,760 units OUS
Sold at
Worldwide Distribution - USA (nationwide) including Puerto Rico; and Internationally to: Belgium, Canada, Chile, Mexico, Costa Rica, Kuwait, United Kingdom, Greece, Czech Republic, Latvia, Turkey, China, France, Italy, Brazil, Korea, Germany, Thailand, Egypt, Austria, Dominican Republic, India, Israel, Colombia, Japan, Netherlands, Venezula, Saudi Arabia, Argentina, Malaysia, Sweden, Lebanon, South Korea, Finland, United Arab Emirates, Taiwan, Panama, Uruguay, Singapore, Hong Kong, Ecuador, Peru, Oman, Spain, Lithuania, and South Africa.
Description
A circuit in use was occluded by a blue port cap that was inadvertently attached to the circuit as a result of an internal inspection error and will cause occlusion of gas flow.
Product
Vital Signs Anesthesia Circuits The Ventilator Circuit is intended for use as an interface between a ventilator dependent patient and a ventilator. The Anesthesia Circuit is intended to administer medical gases to a patient during anesthesia. The CPAP Circuit is intended to increase the airway pressure of a patient.
Manufacturer(s)
Vital Signs Colorado Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →