Home / Recalls / Vital Signs Colorado Inc. / Z-0812-2014

Z-0812-2014 Class II Terminated

Recalled by Vital Signs Colorado Inc. — Englewood, CO

FDA device recall Z-0812-2014 was initiated by Vital Signs Colorado Inc. on December 26, 2013 and is designated Class II. 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. The recall status is terminated (terminated July 9, 2014). Affected quantity: 1,827,920 units US , 504,760 units OUS.

Recall Details

Product Type: Devices
Report Date: January 29, 2014
Initiation Date: December 26, 2013
Termination Date: July 9, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1,827,920 units US , 504,760 units OUS

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.

Distribution Pattern

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.

Code Information

PartNumber : 4S78XX00,155512,155518,156505,156545,1576162,1576214,542011,542021,542031,1553196,1572347,1553402,156205,156310,1574701,1574710,1574711,1574712,1574723,1572414,A4JXXXXX,6463,C311123X,C6X1XX1X,207002,C316123X,1560023,201814,1730327,20CF800C,C116123X,1570103,20CT8050,1577112,1552016,A4JXOXXX,CXX61X2X,1552017,1552018,20CT8048,20CT8055,M1171508,M1181639,1552020,M1162025,155200EU,1552017CN,1574792,M1171508VS,M1181639VS,1552026,1552027,1552028,