FDA Medical Device Recalls (openFDA)
Vital Signs Colorado Inc.: Introduction Pack. A device inserted into an endotracheal tube to aid in the intubation procedure.
- Recall number
- Z-1557-2015
- Recalling firm
- Vital Signs Colorado Inc.
- Product
- Introduction Pack. A device inserted into an endotracheal tube to aid in the intubation procedure.
- Status
- Terminated
- Initiated
- 2015-03-13
- Posted
- 2015-04-30
- Terminated
- 2015-10-07
- Reason
- 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.
- Root cause
- Packaging
- Action
- 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).
- 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.
- Lot, serial or model codes
- Catalog Number 3960
- 510(k) numbers
- ["K944729"]
- PMA numbers
- not on file
- Product code
- BSR
- Firm FEI
- 1718887
- Firm city
- Englewood
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28