Recall Record

San Antonio, TX, United States

XENEX Disinfection Services Inc. recalls

1 recall recorded since 2018, most recently on 18 March 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.

Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0

Ongoing Class II Medical devices

Recall started
18 March 2024
Reason
Blackout curtains are no longer recommended as a protective barrier against UV/Ozone exposure to a bystander standing in the same room, but on the other side of the curtain from where a microbial reduction device UV cycle is taking place. Bystanders in the room during the cycle may experience temporary skin reddening, feeling of sand in eyes, nausea, headache, and/or mucous membrane irritation.
Distribution
US Nationwide distribution in the states of AR, AZ, CA, CO, FL, GA, HI, ID, IL, KY, LA, MI, MN, MO, NC, ND, NV, OH, OK, OR, TN, UT, WA, WV, WY.
Initiated
Voluntary: Firm initiated
Recall number
Z-1615-2024

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.