Recall Z-1408-2020— Medtronic, PLC
Class II · Ongoing
Class II FDA medical device recall by Medtronic, PLC, initiated 2020-01-28. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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.
- Recalling firm
- Medtronic, PLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2020-01-28
- Firm location
- North Haven, CT, United States
Product description
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.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.