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U.S. Department of Health and Human Services

Class 2 Device Recall RUSCH TruLite

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  Class 2 Device Recall RUSCH TruLite see related information
Date Initiated by Firm June 30, 2014
Date Posted July 29, 2014
Recall Status1 Terminated 3 on March 21, 2017
Recall Number Z-2130-2014
Recall Event ID 68697
Product Classification Laryngoscope - Product Code CCW
Product RUSCH, TruLite, One-Piece Disposable Laryngoscope Handle Blade Combination, Non-Sterile, Rx Only, Distributed by: Teleflex Medical.
Code Information Product Code: 004660000, (Size Miller 0), Lot numbers: 1306602, 1308602 & 1310602; Product Code: 004660001, (Size Miller 1), Lot numbers: 1306612, 1308612 & 1310612; Product Code: 004660002, (Size Miller 2), Lot numbers: 1306622, 1308622, 1309622 & 1310622; Product Code: 004660003, (Size Miller 3), Lot numbers: 1306632 & 1310632; Product Code: 004660004, (Size Miller 4), Lot numbers: 1306642, 1308642 & 1309642; Product Code: 004660010, (Size Miller 00), Lot numbers: 1306592, 1308592, 1309592, 1312592 & 1401592; Product Code: 004661002, (Size Mac 2), Lot numbers: 1306522, 1308522 & 1310522; Product Code: 004661003, (Size Mac 3), Lot numbers: 1306532, 1308532 & 1310532 and Product Code: 004661004, (Size Mac 4), Lot numbers: 306542, 1308542 & 1309542. 
Recalling Firm/
Manufacturer		 Teleflex Medical
4024 Stirrup Creek Dr
Durham NC 27703-9000
For Additional Information Contact Michael T. Taggart
919-433-4940
Manufacturer Reason
for Recall		 There is a possibility the handle of the laryngoscope may heat up and melt the end cap.
FDA Determined
Cause 2		 Device Design
Action Consignees were notified via letter on/about 06/30/2014.
Quantity in Commerce 6,246 units
Distribution U.S. Nationwide
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.
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