Recall Z-1408-2020 ยท CCW Laryngoscope, Rigid
Medtronic, PLC
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.
| Date | Feb 10, 2020 (initiated Jan 28, 2020) |
| Status | Open, Classified |
| Reason | 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 |
| Root cause | 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 Serv |
| Quantity | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.