FDA Enforcement
Class II
Ongoing
Cobra, 3-Plate EMG ET Tube, 6.0mm, REF: LTE7003PM, not made with natural rubber latex, Rx Only, STERILEEO
Recall: Z-2719-2024
·
Reported September 4, 2024
Enforcement
- Recall Number
- Z-2719-2024
- Event ID
- 94931
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Neurovision Medical Products Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- September 4, 2024
- Initiation Date
- July 1, 2024
- Classification Date
- August 23, 2024
- Address
- 353 San Jon Rd, Ventura, CA, 93001-3250, United States
Description
Cobra, 3-Plate EMG ET Tube, 6.0mm, REF: LTE7003PM, not made with natural rubber latex, Rx Only, STERILEEO
Reason
mislabeling; EMG RLN monitoring kit labeling contains the incorrect tube size.
Code Info
LOT: 051724B/ UDI: B006LTE7003PS52
Distribution
US Nationwide distribution.
Quantity
5 BOXES (25 single kits)