Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1615-2024Class II

LightStrike Blackout Curtains, Part numbers; 610-00008, 610-00009, 610-00019, 610-00020, and 610-00024, used...

XENEX Disinfection Services Inc. / initiated 2024-03-18 / Open, Classified / root cause: design

XENEX Disinfection Services Inc. began a recall of LightStrike Blackout Curtains, Part numbers; 610-00008, 610-00009, 610-00019, 610-00020, and 610-00024, used with the LightStrike Germ-Zapping Robots Models... on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number
Z-1615-2024
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
XENEX Disinfection Services Inc.
Product
LightStrike Blackout Curtains, Part numbers; 610-00008, 610-00009, 610-00019, 610-00020, and 610-00024, used with the LightStrike Germ-Zapping Robots Models: PXUV4D, PXUV5D, LSMUV6-FT, or LSMUV6-SL, for whole room microbial reduction.
Product code
QXJ Whole Room Microbial Reduction Device
Reason for recall
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.
Root cause tag
design
FDA root cause
Device Design
Action
On 3/18/24, correction notices were emailed to customers informing them of the following: 1) Blackout Curtains can continue to be used to block nuisance light coming from an unoccupied room/area where a UV cycle is being executed. It is not necessary to return curtains. 2) If your practice is to use this Blackout Curtain as a protective barrier, discontinue the use in occupied spaces. 3) If you may have further distributed this product, please identify your customers, and notify them at once of this product field correction or provide us with their contact information so the firm can reach out to them. Complete and return the response form. If you have any questions, call the firm at (830) 832-4299 between the hours of 8:00AM and 5:00PM CST Monday through Friday.
Quantity in commerce
377
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.
Product codes and lots
Robot UDI-DIs: 00814122020033, 00814122020064, 00814122020125, 00814122020132. All serial numbers.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1615-2024
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1615-2024Class IIOngoingVoluntary: Firm initiated