Cobra, 3-Plate EMG ET Tube, 6.0mm, REF: LTE7003PM, not made with natural rubber latex, Rx Only, STERILEEO
Recall
- Recall Number
- Z-2719-2024
- Event Number
- 94931
- Firm
- Neurovision Medical Products Inc
- FEI Number
- 1930870
- Product Code
- ETN
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- July 1, 2024
- Posted
- August 23, 2024
- Address
- 353 San Jon Rd, Ventura, CA, 93001-3250
Description
Cobra, 3-Plate EMG ET Tube, 6.0mm, REF: LTE7003PM, not made with natural rubber latex, Rx Only, STERILEEO
mislabeling; EMG RLN monitoring kit labeling contains the incorrect tube size.
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).
US Nationwide distribution.
5 BOXES (25 single kits)