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Recall Observatory FDA recall evidence

Device 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

Z-2586-2024

February 08, 2024

Class II

Product summary

Firm
EYE COMFORT CARE LLC
Event
Event 94929
Status
Completed
Classification
Class II
Quantity
500
Official record key
device-enforcement:Z-2586-2024

Official wording

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 information: Lot Code: AG23JW24 Serial # ag22

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.