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U.S. Department of Health and Human Services

Class 2 Device Recall Green RuschLite Disposable Metal Larynogoscope Blade.

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 Class 2 Recall
Green RuschLite Disposable Metal Larynogoscope Blade.
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Date Posted November 20, 2013
Recall Status1 Open
Recall Number Z-0366-2014
Recall Event ID 66640
Product Classification Laryngoscope, Rigid - Product Code CCW
Product Green Rusch - Lite Disposable Metal Laryngoscope Ridge Blade to visualize upper airway and aid in placement of tracheal tube.
Code Information Product Code 004551004; Lot 1305342
Recalling Firm/
Manufacturer
Teleflex Medical
4024 Stirrup Creek Dr
Durham, North Carolina 27703-9000
For Additional Information Contact Michael Taggart
919-433-4816
Manufacturer Reason
for Recall
Labeling inconsistency
Action Recall letters were sent to customers and distributors on 10/15/2013 via courier. The letter indicated that the consignee was to immediately discontinue use and quarantine any products with the affected catalog numbers. The letter also included a Recall Acknowledgment Form which was to be faxed back to the firm.
Quantity in Commerce 6,200 ea.
Distribution Nationwide distribution: AL, AZ, CA, CO, FL, GA, IL, IN, IA, KY, LA, MD, MA, MI, MN, MO, NE, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, VA, WA, WV and WI.
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
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