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U.S. Department of Health and Human Services

Class 2 Device Recall Orotracheal Lighted Stylet

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  Class 2 Device Recall Orotracheal Lighted Stylet see related information
Date Initiated by Firm August 11, 2008
Date Posted September 21, 2008
Recall Status1 Terminated 3 on January 10, 2011
Recall Number Z-2455-2008
Recall Event ID 49140
510(K)Number K944729  
Product Classification Tracheal tube stylet - Product Code BSR
Product Vital Signs Intubation Pack, Part Number: INTPKF, Sterile, Vital Signs Colorado Inc, Englewood, CO 80112. Contains one lighted stylet per pack.
Code Information Lot numbers: X144, X172, X217, X273, X299, X300, X307, X333, X350, 052A, 081A, 093A, 166A, 271A, 319A, 349A, 033D, 101D, 116D, 164D, 219D, 233D, 291D, 346D, 004F, 058F, 063F, 197F.
Recalling Firm/
Manufacturer		 Vital Signs Colorado Inc.
11039 East Lansing Circle
Englewood CO 80112-5909
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 73 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
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.
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