Vital Signs Colorado, Inc.
Country not established
- Devices
- 1
- FDA recalls
- 8
At a glance
Market reach
- United States
- FDA recalls
What Vital Signs Colorado, Inc. makes
Vital Signs Colorado, Inc. manufactures the IMASK device in models 100, 200, and 300.
These devices are classified as Class II medical devices and are listed in the FDA 510(k) registry; the company is based in the United States.
Catalogue
Imask, Models 100, 200 And 300 Ref K051559
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 8 recalls initiated by Vital Signs Colorado, Inc., the earliest on 2008-08-11 and the most recent on 2015-03-13. By recorded status: 8 terminated. The reasons filed fall into these groups: sterility or contamination, packaging, electrical or power and mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2015
- 13 Mar 2015 Z-1556-2015 Class II Terminated Vital Signs Colorado (dba CareFusion) is recalling Vital Signs LightWand Stylet catalog numbers 3910 and 3960 due to a potential patient safety risk involving a breach in the sterile packaging that may not be recognized prior to use.
Full distribution text
- 13 Mar 2015 Z-1557-2015 Class II Terminated Vital Signs Colorado (dba CareFusion) is recalling Vital Signs LightWand Stylet catalog numbers 3910 and 3960 due to a potential patient safety risk involving a breach in the sterile packaging that may not be recognized prior to use.
Full distribution text
- 13 Mar 2015 Z-1556-2015 Class II Terminated Vital Signs Colorado (dba CareFusion) is recalling Vital Signs LightWand Stylet catalog numbers 3910 and 3960 due to a potential patient safety risk involving a breach in the sterile packaging that may not be recognized prior to use.
2013
- 26 Dec 2013 Z-0812-2014 Class II Terminated 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.
Full distribution text
- 26 Dec 2013 Z-0812-2014 Class II Terminated 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.
2012
- 17 Aug 2012 Z-0407-2013 Class II Terminated There is a potential for epistaxis during use of the Disposable General Purpose 9 French Temperature Probe.
Full distribution text
- 17 Aug 2012 Z-0407-2013 Class II Terminated There is a potential for epistaxis during use of the Disposable General Purpose 9 French Temperature Probe.
2010
- 20 Dec 2010 Z-1024-2011 Unclassified (pre-2012) Terminated Battery which powers the laryngeal scope light may dislodge resulting in loss of illumination.
Full distribution text
- 20 Dec 2010 Z-1024-2011 Unclassified (pre-2012) Terminated Battery which powers the laryngeal scope light may dislodge resulting in loss of illumination.
2008
- 11 Aug 2008 Z-2454-2008 Unclassified (pre-2012) Terminated Light protector may detach from lighted stylet during intubation.
Full distribution text
- 11 Aug 2008 Z-2455-2008 Unclassified (pre-2012) Terminated Light protector may detach from lighted stylet during intubation.
Full distribution text
- 11 Aug 2008 Z-2456-2008 Unclassified (pre-2012) Terminated Light protector may detach from lighted stylet during intubation.
Full distribution text
- 11 Aug 2008 Z-2454-2008 Unclassified (pre-2012) Terminated Light protector may detach from lighted stylet during intubation.
Frequently asked questions
How many devices does Vital Signs Colorado, Inc. have in the registry?
The registry currently lists 1 device for Vital Signs Colorado, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Vital Signs Colorado, Inc.'s devices?
Among its 1 most recently registered device, Vital Signs Colorado, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Vital Signs Colorado, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Vital Signs Colorado, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Vital Signs Colorado, Inc.?
FDA recall records list 8 recalls initiated by Vital Signs Colorado, Inc., the most recent initiated on 13 Mar 2015. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Vital Signs Colorado, Inc. in the registry?
The most recently registered devices listed for Vital Signs Colorado, Inc. include IMASK, MODELS 100, 200 AND 300.