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Medical Device Recalls
Class 2 Recall
Green Spec Fiberoptic Laryngoscope Handle - Stubby/Short
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Date Recall
Initiated |
June 15, 2006
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| Date Posted |
July 13, 2006
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| Recall Number |
Z-1225-06
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| 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
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| 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.
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Recalling Firm/
Manufacturer |
Teleflex Medical
2345 Waukegan Rd Ste 120
Bannockburn
, Illinois
60015-1580
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| For Addition Information Contact |
Ms. Julie McDowell
610-948-2836
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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.
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| 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.
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| Quantity in Commerce |
1,408 laryngoscopes
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| Distribution |
Nationwide and Canada, Colombia, Costa Rica and Chile.
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