Z-2719-2024Class II

Cobra, 3-Plate EMG ET Tube, 6.0mm, REF: LTE7003PM, not made with natural rubber latex, Rx Only, STERILEEO

Name: Z-2719-2024 Cobra, 3-Plate EMG ET Tube, 6.0mm, REF: LTE7003PM, not made with natural rubber latex, Rx Only, STERILEEO
Creator: Neurovision Medical Products Inc
Published: 2024-07-01
License: https://open.fda.gov/license/

Neurovision Medical Products Inc / initiated 2024-07-01 / Open, Classified / root cause: manufacturing process

FDA source

Neurovision Medical Products Inc began a recall of Cobra, 3-Plate EMG ET Tube, 6.0mm, REF: LTE7003PM, not made with natural rubber latex, Rx Only, STERILEEO on 2024-07-01. FDA classified it as Class II and gives the reason as "mislabeling; EMG RLN monitoring kit labeling contains the incorrect tube size". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2719-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-07-01
Posted: 2024-08-23
Recalling firm: Neurovision Medical Products Inc
Product: Cobra, 3-Plate EMG ET Tube, 6.0mm, REF: LTE7003PM, not made with natural rubber latex, Rx Only, STERILEEO
Product code: ETN Stimulator, Nerve
Reason for recall: mislabeling; EMG RLN monitoring kit labeling contains the incorrect tube size.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 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 commerce: 5 BOXES (25 single kits)
Distribution: US Nationwide distribution.
Product codes and lots: LOT: 051724B/ UDI: B006LTE7003PS52

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2719-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2719-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-04	2024-08-23

Product code ETN

K110989Class IINeurovision Ink Printed Endotracheal Tube ElectrodeNeurovision Medical Products, Inc. / cleared 2011-11-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)