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U.S. Department of Health and Human Services

Class 2 Device Recall Green Spec Fiberoptic Laryngoscope Handle Stubby/Short

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  Class 2 Device Recall Green Spec Fiberoptic Laryngoscope Handle Stubby/Short see related information
Date Initiated by Firm June 15, 2006
Date Posted July 13, 2006
Recall Status1 Terminated 3 on August 28, 2009
Recall Number Z-1225-06
Recall Event ID 35669
510(K)Number K883414  
Product Classification Laryngoscope Handle - Product Code CCW
Product Green Spec Fiberoptic Laryngoscope Handle - Stubby/Short; a battery operated fiberoptic laryngoscope handle for use with green coded fiberoptic systems and single use laryngoscope blades; Teleflex Medical, Bannockburn, IL 60015; catalog number 004413300
Code Information catalog number 004413300, any lot number greater than and including 050901. Please note: the lot number is located at the top of the handle, where the laryngoscope hinge attaches to the blade.
Recalling Firm/
Manufacturer
Teleflex Medical
2345 Waukegan Rd Ste 120
Bannockburn IL 60015-1580
For Additional Information Contact Ms. Julie McDowell
610-948-2836
Manufacturer Reason
for Recall
Teleflex Medical has identified that the product may malfunction, causing the handle to heat up. There is a potential for the heated handle to burn the user.
FDA Determined
Cause 2
Component change control
Action Teleflex Medical sent Urgent Medical Device Recall letters dated 6/15/06 to the direct accounts, informing them of the potential for the handle to heat up, and requesting that they cease use of the affected units and return them to Teleflex Medical for replacement. The accounts were instructed to complete and return by fax the enclosed Acknowledgement & Stock Status Form, indicating the number of units being returned for replacement. Any questions were directed to Linda Todd at 1-800-334-9751, ext. 4951.
Quantity in Commerce 1,408 laryngoscopes
Distribution Nationwide and Canada, Colombia, Costa Rica and Chile.
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 = CCW and Original Applicant = TRUPHATEK, LTD.
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