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Open, Classified

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

FDA Recall Z-2719-2024 · Posted 2024-08-23

Recall StatusOpen, Classified
Product CodeETN
Date Initiated2024-07-01
Product Quantity5 BOXES (25 single kits)

Reason for Recall

mislabeling; EMG RLN monitoring kit labeling contains the incorrect tube size.

Firm 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).

Root Cause

Process control

Distribution Pattern

US Nationwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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