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U.S. Department of Health and Human Services

Class 2 Device Recall Rusch MRI Conditional Fiber Optic Laryngoscope Kit

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 Class 2 Recall
Rusch MRI Conditional Fiber Optic Laryngoscope Kit
see related information
Date Posted May 02, 2007
Recall Status1 Terminated on May 03, 2007
Recall Number Z-0758-2007
Recall Event ID 37591
Premarket Notification
510(K) Number
K062523 
Product Classification Laryngoscope, Rigid - Product Code CCW
Product Conditional Fiber Optic Laryngoscope Kit, which contains laryngoscope blades, handles and 2 battery packs for use in Magnetic Resonance environments; Distributed by Teleflex Medical, Research Triangle Park, NC 27709; catalog number 005852300
Code Information catalog number 005852300, battery lot numbers 065201-065228, 065231, 065232, 065233
Recalling Firm/
Manufacturer
Teleflex Medical
2345 Waukegan Rd Ste 120
Bannockburn, Illinois 60015-1580
For Additional Information Contact Ms. Julie McDowell
610-948-2836
Manufacturer Reason
for Recall
The MRI Battery is out of specification for its magnetic content.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Teleflex telephoned the account on 3/1/07, and faxed them a follow-up recall letter on the same date. The account was informed that the batteries did not meet specification, and was requested to check the batteries in the laryngoscope kit shipped to them for the affected battery lot numbers, and return the affected batteries to Teleflex for replacement. Any questions were directed to Linda Todd at 1-800-334-9751, ext. 4951.
Quantity in Commerce 1 kit
Distribution Georgia
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = CCW and Original Applicant = TRUPHATEK INTERNATIONAL, LTD.
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