| Class 2 Device Recall Orotracheal Lighted Stylet |  |
Date Initiated by Firm | August 11, 2008 |
Date Posted | September 21, 2008 |
Recall Status1 |
Terminated 3 on January 10, 2011 |
Recall Number | Z-2456-2008 |
Recall Event ID |
49140 |
510(K)Number | K944729 |
Product Classification |
Tracheal tube stylet - Product Code BSR
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Product | Light Wand Intro Pack, Part Number: 3960, Sterile, Vital Signs Colorado, Inc., Englewood, CO. Contains 5 lighted stylets per pack. |
Code Information |
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. |
Recalling Firm/ Manufacturer |
Vital Signs Colorado Inc. 11039 East Lansing Circle Englewood CO 80112-5909
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For Additional Information Contact | 303-790-4835 |
Manufacturer Reason for Recall | Light protector may detach from lighted stylet during intubation. |
FDA Determined Cause 2 | 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = BSR
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