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This recall involves the HEROISK and TALRIKA bowls, plates, and mugs made from PLA (Polylactic acid or polylactide) material from renewable sources. The bowls, plates and mugs were sold in a variety of colors, including yellow, pink and blue. The article name ("HEROISK" or "TALRIKA"), supplier number "23348," "Made in Taiwan" and "PLA" are molded into the bottom of each item.
(1) Updated IFU for the LX Illumination Packs: Warning - Avoid contact between the distal opening of the delivery sleeve and tissue/debris within the surgical.field to prevent complete occlusion. Some surgical approaches (e.g., endonasal) may increase this potential. {f unintended reduction in light output occurs and/or occlusion of the sleeve is suspected, both the delivery sleeve and the fiber should be replaced (2) Removal for the LX Light Source potential for the distal tip of the sleeve/fiber assembly potential to burn healthy tissue resulting in minor to moderate injury to the patient or end user.