Recall Z-2456-2008
Vital Signs Colorado Inc. · initiated August 11, 2008
Product
Light Wand Intro Pack, Part Number: 3960, Sterile, Vital Signs Colorado, Inc., Englewood, CO. Contains 5 lighted stylets per pack.
Codes / 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.
Reason for recall
Light protector may detach from lighted stylet during intubation.
FDA-determined cause: Device Design
Action taken
Consignees were notified by letter on 08/11/2008, and instructed to return any unopened and sealed product for replacement.
Details
- Recall number
- Z-2456-2008
- Initiated
- August 11, 2008
- Posted by FDA
- September 21, 2008
- Terminated
- January 10, 2011
- Product code
- BSR – Stylet, Tracheal Tube
- Quantity
- 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…
- Recalling firm
- Vital Signs Colorado Inc., Englewood, CO
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2454-2008 | Light Wand Orotracheal Lighted Stylet, Part number: 3910. Sterile, Vital Signs Colorado…Light protector may detach from lighted stylet during intubation. | 08/11/2008Terminated |
| Z-2455-2008 | Vital Signs Intubation Pack, Part Number: INTPKF, Sterile, Vital Signs Colorado Inc…Light protector may detach from lighted stylet during intubation. | 08/11/2008Terminated |