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 s
Check against the official notice below — it lists the full affected range.
Medtronic has recalled McGRATH X3 Disposable Laryngoscope Blades (model codes X3-002-000 and X3-003-000) used with McGRATH MAC Video Laryngoscopes. The blades either do not fit the laryngoscope handle or fit too tightly, which can cause changes in optical performance on the video screen. Approximately 109,897 units have been distributed worldwide across numerous countries including the United States, Canada, Australia, Japan, and various European nations.
The affected blades are identified by specific lot and serial numbers ranging from M1811191 through M1906121, with UDI 15060272980082. The source document does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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
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 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, Norw Quantity: 109,897 Lot/code info: UDI: 15060272980082 Lot/Serial #: M1811191 M1811261 M1812071 M1812271 M1901081 M1901161 M1902251 M1903131 M1904031 M1904241 M1906031 M1906121
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.