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FDA (Device enforcement)Recalled 2022-04-29class i

Medtronic Xomed, Inc.: NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229308 b) REF 8229307 c) REF 8229306

Is my product affected?

NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229308 b) REF 8229307 c) REF 8229306

  • UPC 00643169789548
  • UPC 00763000745837
  • UPC 00763000882402
  • UPC 00643169789531
  • UPC 00763000745820
  • UPC 00763000882396
  • UPC 00643169789524
  • UPC 00763000745813
  • UPC 00763000882389

Check against the official notice below — it lists the full affected range.

What happened

Medtronic Xomed, Inc. is recalling NIM EMG Endotracheal Tubes (part numbers REF 8229308, REF 8229307, and REF 8229306) due to reports of airway obstruction events during use. The recall affects approximately 1.1 million units that were distributed worldwide, including throughout the United States and numerous foreign countries. All lots of these three part numbers are included in the recall.

The recall covers NIM Standard Reinforced EMG Endotracheal Tubes and NIM CONTACT Reinforced EMG Endotracheal Tubes. According to the recall record, no remedy information is specified.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes.

Details from the source

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: 1,133,612 units Lot/code info: a) REF 8229308; UDI 00643169789548, 00763000745837, 00763000882402; ALL LOTS. b) REF 8229307; UDI 00643169789531, 00763000745820, 00763000882396; ALL LOTS. c) REF 8229306; UDI, 00643169789524, 00763000745813, 00763000882389; ALL LOTS.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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