Device product
Cobra, 3-Plate EMG ET Tube, 6.0mm, REF: LTE7003PM, not made with natural rubber latex, Rx Only, STERILEEO
Z-2719-2024
Product summary
- Event
- Event 94931
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5 BOXES (25 single kits)
- Official record key
device-enforcement:Z-2719-2024
Official wording
Reason: mislabeling; EMG RLN monitoring kit labeling contains the incorrect tube size.
Code information: LOT: 051724B/ UDI: B006LTE7003PS52
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Labeling or packaging
mislabeling