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U.S. Department of Health and Human Services

Class 2 Device Recall McGrath

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  Class 2 Device Recall McGrath see related information
Date Initiated by Firm January 28, 2020
Date Posted February 10, 2020
Recall Status1 Open3, Classified
Recall Number Z-1408-2020
Recall Event ID 84819
Product Classification Laryngoscope, rigid - Product Code CCW
Product McGRATH X3 Disposable Laryngoscope Blades-used with the McGRATH MAC Video Laryngoscope to aid the intubation of the trachea
Code: X3-002-000 (Individual Unit); X3-003-000 (Carton of 10 Units) - Product Usage: is a tool used to aid the intubation of the trachea. As a rigid laryngoscope it holds and shapes the anatomy allowing a clear view of the larynx and entrance to the trachea.
Code Information UDI: 15060272980082 Lot/Serial #: M1811191 M1811261 M1812071 M1812271 M1901081 M1901161 M1902251 M1903131 M1904031 M1904241 M1906031 M1906121 
Recalling Firm/
Manufacturer		 Medtronic, PLC
60 Middletown Ave
North Haven CT 06473-3908
For Additional Information Contact SAME
203-492-5000
Manufacturer Reason
for Recall		 Blades do not fit the McGRATH MAC video laryngoscope handle or were tight fitting on the handles which may result in a change in optical performance as displayed on the video screen
FDA Determined
Cause 2		 Under Investigation by firm
Action Medtronic issued Medical Device Correction letter via Federal Express and/or certified mail beginning January 28, 2020. The letter states reason for recall, health risk and action to take: dispose of affected product according to their institutions disposal procedures;" Notify all care environments about this notice in which the McGRATH" X3 disposable laryngoscope blades are used;" Promptly forward the information from the customer communication to any recipients to whom they have distributed any of the affected; product; Complete the acknowledgment and receipt form. Questions: Customer Service at (800) 448-3644, Option 2, Option 2.
Quantity in Commerce 109,897
Distribution Worldwide distribution - US Nationwide and countries Australia, Canada, New Zealand, India, Korea, Japan, Indonesia, Malaysia, Philippines, Singapore, Vietnam, Latin America, France, Switzerland. Italy, Belgium, Germany, Netherlands, Denmark, Poland, Austria, Czech Republic, Croatia, Spain, Finland,Greece, Guadeloupe, Ireland, Hungry, Italy, Jordan, Kazakhstan, Lithuania, Lebanon, Luxembourg, Norway, Poland, Portugal, Reunion, Romania, Russian Federation, Saudia Arabia, Sweden, Serbia, Slovakia, Turkey, Tunisia, United Arab Emirates, United Kingdom.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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