Z-2456-2008

Light Wand Intro Pack, Part Number: 3960, Sterile, Vital Signs Colorado, Inc., Englewood, CO. Contains 5...

Name: Z-2456-2008 Light Wand Intro Pack, Part Number: 3960, Sterile, Vital Signs Colorado, Inc., Englewood, CO. Contains 5...
Creator: Vital Signs Colorado Inc.
Published: 2008-08-11
License: https://open.fda.gov/license/

Vital Signs Colorado, Inc. / initiated 2008-08-11 / Terminated / root cause: design

FDA source

Vital Signs Colorado Inc. began a recall of Light Wand Intro Pack, Part Number: 3960, Sterile, Vital Signs Colorado, Inc., Englewood, CO. Contains 5 lighted stylets per pack on 2008-08-11. The reason FDA records is "Light protector may detach from lighted stylet during intubation". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2456-2008
Status: Terminated
Initiated: 2008-08-11
Posted: 2008-09-21
Terminated: 2011-01-10
Recalling firm: Vital Signs Colorado, Inc.
Product: Light Wand Intro Pack, Part Number: 3960, Sterile, Vital Signs Colorado, Inc., Englewood, CO. Contains 5 lighted stylets per pack.
Product code: BSR Stylet, Tracheal Tube
Reason for recall: Light protector may detach from lighted stylet during intubation.
Root cause tag: design
FDA root cause: Device Design
Action: Consignees were notified by letter on 08/11/2008, and instructed to return any unopened and sealed product for replacement.
Quantity in commerce: 1,121 pieces
Distribution: Worldwide including states of CA, OH, MD, NC, TX and VA facilities in GA, IN, MS, NC, NJ, NM, NY, and VA. Foreign distribution to Argentina, Australia, Canada, Chile, China, Colombia, Dominican Republic, Dubai, Ecuador, Egypt, Germany, Hong Kong, India, Indonesia, Israel, Italy, Korea, Malaysia, Mexico, Nepal, Netherlands, New Zealand, Philippines, Qatar, Republic of China, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Thailand, UK, and Venezuela.
Product codes and lots: Lot numbers: 1080D, 1397D, 1623D, 2079D, 2654D, 2949D, 3165D, 3168I, 3207D, 3316H, 3583F, 3693E, 4378W, 4400P, 8045C, 9144C, 9863C, 4022K, 4059F, 4101L, 4198B, 4289Y, 4307A.

Product code BSR

K944729Class IStylet Sheath with Locking Cap and Reusable Battery Operated Light SourceCoast Medical, Inc. / cleared 1994-12-21

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)