FDA Recall 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 · Initiated February 8, 2024

Recall

Recall Number
Z-2586-2024
Event Number
94929
Firm
EYE COMFORT CARE LLC
FEI Number
3017065824
Product Code
IRT
Status
Completed
Root Cause
Vendor change control
Initiated
February 8, 2024
Posted
August 14, 2024
Address
57765 Nw Wilson River Hwy, Gales Creek, OR, 97117-9359

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.

Action

Between 02/08/2024 to 05/18/2024, the firm send via email, a Stop Sale Notice and an "Voluntary Product Recall Notice" for it UNCLOG Heated Eye Masks (Lot Model# AG23JN24) inform customers that an unauthorized material substitution was made in the manufacturing process of these masks. Additionally, it was identified that a smaller safety clip was used and could compromise the integrity of the mask. Customers are instructed to: 1. Cease Use Immediately. Stop using the UNCLOG Heated Eye Mask to avoid any potential risks. 2. Claim a replacement. The firm is committed to replacing their current masks with a new, fully tested new UNCLOG eye mask at no additional cost. Any questions or assistance, contact Vivian Surya, Founder/CEO of Eye Comfort Care LLC at 888-781-2811 or email at [email protected]

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