NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229307J b) REF 8229308J c) REF 8229306J
Check against the official notice below — it lists the full affected range.
Medtronic Xomed is recalling NIM Standard Reinforced EMG Endotracheal Tubes and NIM CONTACT Reinforced EMG Endotracheal Tubes (part numbers 8229307J, 8229308J, and 8229306J) due to reports of airway obstruction events during use. A total of 23,820 units have been distributed worldwide, including throughout the United States and numerous foreign countries.
The recall affects all lots of the three affected part numbers. The source document does not specify what actions affected consumers or healthcare facilities should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes.
Reason for recall: The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes. Distribution: Worldwide distribution: US (nationwide) and OUS (foreign) countries of: Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, French Guiana, Germany, Greece, Hong Kong, Hungary, Iceland, India, Iran, Islamic Republic Of, Ireland, Israel, Italy, Japan, Korea, Republic Of, Kosovo, Kuwait, Li Quantity: 23,820 units Lot/code info: a) REF 8229307J, UDI 00613994415462, ALL LOTS; b) REF 8229308J, UDI 00613994415431, ALL LOTS; c) REF 8229306J, UDI 00613994415455, ALL LOTS
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.