Recall Z-2719-2024 ยท ETN Stimulator, Nerve
Neurovision Medical Products Inc
Cobra, 3-Plate EMG ET Tube, 6.0mm, REF: LTE7003PM, not made with natural rubber latex, Rx Only, STERILEEO
| Date | Aug 23, 2024 (initiated Jul 1, 2024) |
| Status | Open, Classified |
| Reason | mislabeling; EMG RLN monitoring kit labeling contains the incorrect tube size. |
| 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 transferr |
| Quantity | 5 BOXES (25 single kits) |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110989 | NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE Neurovision Medical Products, Inc., Nov 3, 2011 |