NIM CONTACT EMG Endotracheal Tube, Part Numbers: a) REF 8229508 b) REF 8229507 c) REF 8229506
Check against the official notice below — it lists the full affected range.
Medtronic Xomed, Inc. is recalling NIM CONTACT EMG Endotracheal Tubes (part numbers REF 8229508, REF 8229507, and REF 8229506) due to reports of airway obstruction events during use. The recall affects approximately 81,555 units that were distributed worldwide, including throughout the United States and numerous countries in Europe, Asia, the Middle East, Africa, and the Americas.
The recall covers all lots of the three affected part numbers, identified by their specific UDI codes. The source document does not specify what actions affected consumers 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: 81,555 units Lot/code info: a) REF 8229508; UDI 00643169789579, 00763000745868, 00763000882433; ALL LOTS. b) REF 8229507; UDI 00643169789562, 00763000745851, 00763000882426; ALL LOTS. c) REF 8229506; UDI 00643169789555, 00763000745844, 00763000882419; ALL LOTS.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.