Z-0812-2014Class II

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

Name: Z-0812-2014 Vital Signs Anesthesia Circuits The Ventilator Circuit is intended for use as an interface between a...
Creator: Vital Signs Colorado Inc.
Published: 2013-12-26
License: https://open.fda.gov/license/

Vital Signs Colorado, Inc. / initiated 2013-12-26 / Terminated / root cause: manufacturing process

FDA source

Vital Signs Colorado Inc. began a recall of Vital Signs Anesthesia Circuits The Ventilator Circuit is intended for use as an interface between a ventilator dependent patient and a ventilator. The... on 2013-12-26. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0812-2014
Classification: Class II
Status: Terminated
Initiated: 2013-12-26
Posted: 2014-01-23
Terminated: 2014-07-09
Recalling firm: Vital Signs Colorado, Inc.
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.
Product code: CAH Filter, Bacterial, Breathing-Circuit
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: GE Healthcare sent an Urgent Medical Device Correction letter on December 12, 2013 to all affected customers via certified letter to follow the safety instructions to: 1) Please follow all safety instructions in accordance with the instructions for use (IFU). 2) During installation, visually inspect the Vital Signs Breathing Circuits for any plugged ports. If 15mm or 22mm blue port caps are attached to any ports, please remove and discard. 3) Prior to use, the circuits should be pressure tested for leaks and flow tested for obstructions in accordance with the ventilator manufacturers specifications. The long-term solution is to update the instructions for the assembly operator and modify the circuit air test process by replacing the cap with a plug tethered to the workstation so the plug cannot be left on the circuit. If you have any questions or concerns regarding this notification, please contact GEMSIT Customer Service at +1-800-588-7044 (Domestic) or Vital Signs Customer Service at +1-800-932-0760 (International). Hours of Operation: 8:00 am EST to 6:00 pm EST. Please be assured that maintaining a high level of safety and quality is our highest priority. If you have any questions, please contact us immediately per the contact information above.
Quantity in commerce: 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.
Product codes and lots: 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,

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0812-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0812-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-29	2014-01-23

Product code CAH

K831856Class IIBreathing Circuit Bacteria FilterVital Signs, Inc. / cleared 1983-09-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)