FDA Enforcement
Class II
Completed
Brand Name: UNclog Eye Mask Product Name: UNclog Eye Mask Model/Catalog Number: AG23JW24 Serial # ag22 Product Description: Heated eye mask Component: Heating unit, wire
Recall: Z-2586-2024
·
Reported August 21, 2024
Enforcement
- Recall Number
- Z-2586-2024
- Event ID
- 94929
- Classification
- Class II
- Status
- Completed
- Product Type
- Devices
- Firm
- EYE COMFORT CARE LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 21, 2024
- Initiation Date
- February 8, 2024
- Classification Date
- August 14, 2024
- Address
- 57765 Nw Wilson River Hwy, Gales Creek, OR, 97117-9359, United States
Description
Brand Name: UNclog Eye Mask Product Name: UNclog Eye Mask Model/Catalog Number: AG23JW24 Serial # ag22 Product Description: Heated eye mask Component: Heating unit, wire
Reason
Due to a change in the safety clips for the heated eye masks, the wires to the safety clips may detach as a result of tugging and pulling and may cause a short in the heating element of the mask and could potentially cause burn injuries.
Code Info
Lot Code: AG23JW24 Serial # ag22
Distribution
U.S. Nationwide distribution in the states of AL, AZ, CA, CT, FL, KS, KY, MA, ME, MT, NC, ND, NJ, NM, NY, OH, OR, PA, SC, TX, VA, WA, and WI.
Quantity
500