Recall Z-2719-2024— Neurovision Medical Products Inc

Name: FDA recall Z-2719-2024
Creator: U.S. Food and Drug Administration
Published: 2024-07-01

Class II · Ongoing

Class II FDA medical device recall by Neurovision Medical Products Inc, initiated 2024-07-01. It names one FDA 510(k) clearance: K110989. Product: 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..

Recalling firm: Neurovision Medical Products Inc
Classification: Class II
Status: Ongoing
Initiated: 2024-07-01
Firm location: Ventura, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K110989 — NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODENeurovision Medical Products, Inc.·cleared 2011-11-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.