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U.S. Department of Health and Human Services

Class 1 Device Recall NIM EMG Endotracheal Tube

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  Class 1 Device Recall NIM EMG Endotracheal Tube see related information
Date Initiated by Firm April 29, 2022
Date Posted September 01, 2022
Recall Status1 Open3, Classified
Recall Number Z-1521-2022
Recall Event ID 90711
Product Classification Stimulator, nerve - Product Code ETN
Product NIM EMG Endotracheal Tube, Part Numbers:
a) REF 8229307J
b) REF 8229308J
c) REF 8229306J
Code Information a) REF 8229307J, UDI 00613994415462, ALL LOTS; b) REF 8229308J, UDI 00613994415431, ALL LOTS; c) REF 8229306J, UDI 00613994415455, ALL LOTS
Recalling Firm/
Manufacturer		 Medtronic Xomed, Inc.
6743 Southpoint Dr N
Jacksonville FL 32216-6218
For Additional Information Contact Marie Gentile
404-693-6028
Manufacturer 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 2		 Under Investigation by firm
Action 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: 1. Immediately deflate the cuff and attempt to ventilate. 2. If ventilation cannot be re-established: a. Extubate the NIM Standard Reinforced EMG Endotracheal Tube or NIM CONTACT Reinforced EMG Endotracheal Tube from the patient b. Re-establish ventilation with Bag Valve Mask (BVM} or Laryngeal Mask Airway (LMA). c. Reintubate with a new PVC Endotracheal Tube or, if surgically needed, re-intubate the patient with a new, larger NIM Standard Reinforced EMG Endotracheal Tube or NIM CONTACT Reinforced EMG Endotracheal Tube which requires less cuff inflation volume and pressure. Additional Discussion for Using a NIM Standard Reinforced EMG Endotracheal Tube & NIM CONTACT Reinforced EMG Endotracheal Tube: Intubate the patient using standard of care and medical training and knowledge. Per the IFU, use care when manipulating the tube's position. Manipulating an inflated tube can cause the inflated cuff to stretch over the tube opening and may cause patient airway obstruction. Deflate the cuff before manipulating or repositioning the tube and/or patient. Then assess tube placement and non-occlusion. Copies of the updated IFU will be disseminated when available. 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.
Quantity in Commerce 9808 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, Libya, Lithuania, Luxembourg, Mexico, Netherlands, New Zealand, North Macedonia, Northern Mariana Islands, Norway, Oman, Panama, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Slovakia, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Viet Nam
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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