Vital Signs Anesthesia Circuits The Ventilator Circuit recall
Vital Signs Anesthesia Circuits The Ventilator Circuit is intended for use as an interface between a ventilator dependent patient and a ventilator.…
Why was Vital Signs Anesthesia Circuits The Ventilator Circuit recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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,
- Product
- Vital Signs Anesthesia Circuits The Ventilator Circuit is intended for use as an interface between a ventilator dependent patient and a ventilator.…
- Recalling firm
- Vital Signs Colorado Inc.
- Quantity
- 1,827,920 units US , 504,760 units OUS
- Distribution
- 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.
- Recall date
- January 29, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)