NIM CONTACT EMG Endotracheal Tube, Part Numbers: a) REF 8229508 b) REF 8229507 c) REF 8229506
FDA device recall Z-1519-2022 · posted 2022-09-01 · Open, Classified
Recall details
- Recalling firm
- Medtronic Xomed, Inc.
- 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.
- Action taken
- Medtronic sent an URGENT: MEDICAL DEVICE SAFETY NOTICE to impacted customers on 29-APR-2022 by mail. The letter explained the problem and provided Recommended Actions when using NIM Standard Reinforced EMG Endotracheal Tube & NIM CONTACT" Reinforced EMG Endotracheal Tube and airway obstruction is encountered. Medtronic posted this issue to its US Product Performance and Advisories Information for Healthcare Professionals website on 3-May-2022. If you have any questions, contact your Medtronic ENT representative. Within the US, beginning 30-Jan-2024, Medtronic distributed a follow-up a notice via mail courier to all impacted consignees about availability of the updated IFU. On about 07/08/2024, Medtronic distributed an additional notification to consignees to notify them to remove all lots of the NIM Contact" EMG Reinforced Endotracheal Tubes and NIM" (Standard) EMG Reinforced Endotracheal Tubes. Customers were instructed to not use the affected devices and to identify, segregate, quarantine, and return affected products to Medtronic using the Customer Confirmation Form. https://www.medtronic.com/content/dam/medtronic-wide/public/united-states/products/ear-nose-throat/nim-contact-emg-reinforced-endotracheal-tubes.pdf.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- ETN
- Quantity affected
- 81,555 units
- 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
- Date initiated
- 2022-04-29
- Date posted
- 2022-09-01
- Location
- Jacksonville, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE (K050162) | Medtronic Xomed, Inc. | 2005-03-03 |