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U.S. Department of Health and Human Services

Class 2 Device Recall Cobra, 3Plate EMG ET Tube

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 Class 2 Device Recall Cobra, 3Plate EMG ET Tubesee related information
Date Initiated by FirmJuly 01, 2024
Date PostedAugust 23, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2719-2024
Recall Event ID 94931
510(K)NumberK110989 
Product Classification Stimulator, nerve - Product Code ETN
ProductCobra, 3-Plate EMG ET Tube, 6.0mm, REF: LTE7003PM, not made with natural rubber latex, Rx Only, STERILEEO
Code Information LOT: 051724B/ UDI: B006LTE7003PS52
FEI Number 1930870
Recalling Firm/
Manufacturer		 Neurovision Medical Products Inc
353 San Jon Rd
Ventura CA 93001-3250
For Additional Information ContactChirstie Vergely
866-816-6999
Manufacturer Reason
for Recall		mislabeling; EMG RLN monitoring kit labeling contains the incorrect tube size.
FDA Determined
Cause 2		Process control
ActionOn July 11, 2024, Neurovision Medical Products issued a "Urgent Medical Device Recall Notice" to affected consignees via E-Mail. Neurovision ask consignees to take the following actions: immediately take the following actions: 1. Review your inventory for the lot mentioned above REF code and lot. 2. Quarantine product subject to this notice. 3. Cease distribution and use of any product from the affected lots. 4. Pass this notice on to all who need to be aware within your organization or to any organization where the potentially affected product with the specified lot number has been transferred or distributed. 5. Complete and return the enclosed response form as soon as possible: a. Email: customer service @neurovisionmedical.com b. Fax: (877) 330-1727 6. NMP Customer Service will respond with a return authorization (RMA) number and return shipping label for any remaining stock. 7. If you have distributed this product to another location or entity, notify them of this product recall (include a copy of this notice), and contact NMP Customer Service for return authorization (RMA).
Quantity in Commerce5 BOXES (25 single kits)
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC 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.
510(K) Database510(K)s with Product Code = ETN
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