Cobra, 3-Plate EMG ET Tube, 6.0mm, REF: LTE7003PM, not made with natural rubber latex, Rx Only, STERILEEO
FDA device recall Z-2719-2024 · posted 2024-08-23 · Open, Classified
Recall details
- Recalling firm
- Neurovision Medical Products Inc
- Reason for recall
- mislabeling; EMG RLN monitoring kit labeling contains the incorrect tube size.
- Action taken
- 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
- Status
- Open, Classified
- Product code
- ETN
- Quantity affected
- 5 BOXES (25 single kits)
- Distribution
- US Nationwide distribution.
- Date initiated
- 2024-07-01
- Date posted
- 2024-08-23
- Location
- Ventura, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE (K110989) | Neurovision Medical Products, Inc. | 2011-11-03 |