Recall Z-0812-2014— Vital Signs Colorado Inc.

Name: FDA recall Z-0812-2014
Creator: U.S. Food and Drug Administration
Published: 2013-12-26

Class II · Terminated

Class II FDA medical device recall by Vital Signs Colorado Inc., initiated 2013-12-26, terminated 2014-07-09. It names one FDA 510(k) clearance: K831856. 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.. Reason: 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..

Recalling firm: Vital Signs Colorado Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-12-26
Terminated: 2014-07-09
Firm location: Englewood, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K831856 — BREATHING CIRCUIT BACTERIA FILTERVital Signs, Inc.·cleared 1983-09-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.