Recall Z-2586-2024 ยท IRT Pad, Heating, Powered
EYE COMFORT CARE LLC
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
| Date | Aug 14, 2024 (initiated Feb 8, 2024) |
| Status | Completed |
| 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. |
| Root cause | Vendor change control |
| 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 curren |
| Quantity | 500 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.