Vital Signs Colorado, Inc.
Englewood, CO, US
Vital Signs Colorado, Inc. appears in FDA device records in Englewood, CO. FDA records list one 510(k) clearance, no PMA records and no registered establishments. As of , FDA records show 8 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 1 510(k) clearance for Vital Signs Colorado, Inc. in 2005.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 1 |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1557-2015 | Introduction Pack. A device inserted into an endotracheal tube to aid in the intubation procedure. | 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. | Class II | Terminated | |
| Z-1556-2015 | CareFusion Vital Signs LightWand Stylet. A device inserted into an endotracheal tube to aid in the intubation procedure. | 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. | Class II | Terminated | |
| Z-0812-2014 | 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. | 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. | Class II | Terminated | |
| Z-0407-2013 | Vital Signs Disposable General Purpose 9 French Temperature Probe For monitoring of core temperature | There is a potential for epistaxis during use of the Disposable General Purpose 9 French Temperature Probe. | Class II | Terminated | |
| Z-1024-2011 | Laryngoscope Handle, Reusable, Rx, Product Code 4558GSP or 4559LED, Vital Signs Colorado, Inc., 11039 E. Lansing Circle, Englewood, CO 80112. Used for tracheal tube intubations during anesthesia, intensive care, and emergency medical airway management. | Battery which powers the laryngeal scope light may dislodge resulting in loss of illumination. | Terminated | ||
| Z-2456-2008 | Light Wand Intro Pack, Part Number: 3960, Sterile, Vital Signs Colorado, Inc., Englewood, CO. Contains 5 lighted stylets per pack. | Light protector may detach from lighted stylet during intubation. | Terminated | ||
| Z-2455-2008 | Vital Signs Intubation Pack, Part Number: INTPKF, Sterile, Vital Signs Colorado Inc, Englewood, CO 80112. Contains one lighted stylet per pack. | Light protector may detach from lighted stylet during intubation. | Terminated | ||
| Z-2454-2008 | Light Wand Orotracheal Lighted Stylet, Part number: 3910. Sterile, Vital Signs Colorado Inc., Englewood, CO. , packaged 20 per case. | Light protector may detach from lighted stylet during intubation. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain