Recall Z-1521-2022
Medtronic Xomed, Inc. · initiated April 29, 2022
Class I – dangerous or defective products that could cause serious health problems or death
Product
NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229307J b) REF 8229308J c) REF 8229306J
Codes / lots: a) REF 8229307J, UDI 00613994415462, ALL LOTS; b) REF 8229308J, UDI 00613994415431, ALL LOTS; c) REF 8229306J, UDI 00613994415455, ALL LOTS
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.
FDA-determined cause: Under Investigation by firm
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.
Details
- Recall number
- Z-1521-2022
- Initiated
- April 29, 2022
- Posted by FDA
- September 1, 2022
- Product code
- ETN – Stimulator, Nerve
- Quantity
- 23,820 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 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…
- Recalling firm
- Medtronic Xomed, Inc., Jacksonville, FL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1519-2022 Class I | NIM CONTACT EMG Endotracheal Tube, Part Numbers: a) REF 8229508 b) REF 8229507 c) REF…The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG… | 04/29/2022Open, Classified |
| Z-1520-2022 Class I | NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229308 b) REF 8229307 c) REF 8229306The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG… | 04/29/2022Open, Classified |