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U.S. Department of Health and Human Services

Class 2 Device Recall CareFusion Vital Signs Introduction Pack

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  Class 2 Device Recall CareFusion Vital Signs Introduction Pack see related information
Date Initiated by Firm March 13, 2015
Date Posted April 30, 2015
Recall Status1 Terminated 3 on October 07, 2015
Recall Number Z-1557-2015
Recall Event ID 70753
510(K)Number K944729  
Product Classification Stylet, tracheal tube - Product Code BSR
Product Introduction Pack. A device inserted into an endotracheal tube to aid in the intubation procedure.
Code Information Catalog Number 3960
Recalling Firm/
Vital Signs Colorado Inc.
11039 East Lansing Circle
Englewood CO 80112-5909
For Additional Information Contact Ms. Lindy Schenning
Manufacturer 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 2
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 in Commerce 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.
Total Product Life Cycle TPLC Device Report

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.
510(K) Database 510(K)s with Product Code = BSR and Original Applicant = COAST MEDICAL, INC.