Hangzhou AcoSound Technology Co., Ltd. is recalling 120 units of AcoSound hearing aids (Model LW12-BTE-M) due to multiple labeling errors. The products are mislabeled as being "Developed by" rather than "Manufactured by" the company, missing the manufacturer's place of business, and containing incorrect customer information for "Blaid." Additionally, required safety and identification codes (UDI) are incomplete or incorrect. No incidents or injuries have been reported at this time.
The missing manufacturer business address and incorrect labeling may prevent consumers from contacting the firm in the event of a device failure or safety concern. The incomplete identification codes also make it difficult to track and identify specific units in the event of future safety alerts.
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Labeling identifies manufacturer as 'Developed by AcoSound' instead of 'Manufactured by Hangzhou AcoSound.' Incorrectly lists 'Blaid' as manufacturer.
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Sources: FDA iRES · Raw API Response
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