FDA recall Z-2719-2024

Product

Cobra, 3-Plate EMG ET Tube, 6.0mm, REF: LTE7003PM, not made with natural rubber latex, Rx Only, STERILEEO

Reason for recall

mislabeling; EMG RLN monitoring kit labeling contains the incorrect tube size.

Distribution

US Nationwide distribution.

Key facts

Status

Ongoing

Initiation date

2024-07-01

Report date

2024-09-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Ventura, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2719-2024