Reported Jan 29, 2014 · Terminated

Vital Signs Anesthesia Circuits The Ventilator Circuit is intended for use as an interface between a ventilator…

Vital Signs Colorado Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Vital Signs Colorado Inc. · 11039 East Lansing Circle · Englewood, CO · 80112-5909

Is this the product you have?

  • 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.
Lot codes and dates
  • 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
Amount recalled
1,827,920 units US , 504,760 units OUS

Where it was sold

  • Nationwide
  • PR

Why it was 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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 9, 2014 · Data as of Sep 19, 6:12 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.