Cobra, 3-Plate EMG ET Tube, 6.0mm, REF: LTE7003PM, not made with natural rubber latex, Rx Only, STERILEEO
This recall is currently active, issued August 23, 2024. It was issued by Neurovision Medical Products Inc.
- Company
- Neurovision Medical Products Inc
- Recall Initiated
- July 1, 2024
- Posted
- August 23, 2024
- Recall Number
- Z-2719-2024
- Quantity
- 5 BOXES (25 single kits)
- Firm Location
- Ventura, CA
- Official Source
- View on FDA website ↗
Reason for Recall
mislabeling; EMG RLN monitoring kit labeling contains the incorrect tube size.
Distribution
US Nationwide distribution.
Lot / Code Info
LOT: 051724B/ UDI: B006LTE7003PS52
Root Cause
Process control
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).