Recall Z-1557-2015
Vital Signs Colorado Inc. · initiated March 13, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Introduction Pack. A device inserted into an endotracheal tube to aid in the intubation procedure.
Codes / lots: Catalog Number 3960
Reason for recall
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.
FDA-determined cause: Packaging
Action taken
Customers were notified on 3/13/15 via letter to perform an inventory, complete and return the Recall Response Form within 15 days, and to destroy the product on site (do not return to CareFusion).
Details
- Recall number
- Z-1557-2015
- Initiated
- March 13, 2015
- Posted by FDA
- April 30, 2015
- Terminated
- October 7, 2015
- Product code
- BSR – Stylet, Tracheal Tube
- Quantity
- 399
- Distribution
- Worldwide Distribution. US Nationwide, Australia, Canada, Chile, Colombia, Dominican Republic, Ecuador, Egypt, Germany, Guatemala, Hong Kong, India, Israel, Italy, Japan, South Korea, Lebanon, Mexico, Netherlands, New Zealand, Panama, Peru, Poland, Russia, Slovenia, Turkey, United Kingdom, and Qatar.
- Recalling firm
- Vital Signs Colorado Inc., Englewood, CO
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1556-2015 Class II | CareFusion Vital Signs LightWand Stylet. A device inserted into an endotracheal tube to…Vital Signs Colorado (dba CareFusion) is recalling Vital Signs LightWand Stylet catalog numbers 3910 and… | 03/13/2015Terminated |