Recall Z-2586-2024— EYE COMFORT CARE LLC
Class II · Completed
Class II FDA medical device recall by EYE COMFORT CARE LLC, initiated 2024-02-08. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- EYE COMFORT CARE LLC
- Classification
- Class II
- Status
- Completed
- Initiated
- 2024-02-08
- Firm location
- Gales Creek, OR, United States
Product 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 for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.