AcoSound LW12-BTE-M Hearing Aid Labeling and UDI Information Errors
Hangzhou AcoSound Technology Co., Ltd. is recalling 120 units of the AcoSound Model LW12-BTE-M hearing aid due to labeling errors, including incorrect manufacturer attribution, missing manufacturer business address, and incomplete UDI information.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which by definition is unlikely to cause adverse health consequences. The hazards are labeling and documentation errors with no reported injuries or illnesses, meeting the criteria for a Low severity rating.
Plain-English summary
Hangzhou AcoSound Technology Co., Ltd. is recalling 120 units of the AcoSound Model LW12-BTE-M hearing aid due to three labeling compliance issues. The device's labeling incorrectly attributes the product as "Developed by AcoSound" rather than the correct "Manufactured by Hangzhou AcoSound," and fails to include the manufacturer's place of business as required.
Additionally, the labeling incorrectly identifies "Blaid" as the manufacturer when Blaid is not the manufacturer. The device's UDI (Unique Device Identification) labeling is incomplete, lacking required DI (Device Identifier) information and correct PI (Production Identifier) information, in violation of UDI label requirements.
The recalled devices were distributed nationwide in New York. The affected units are Model LW12-BTE-M with UDI 06973375880000, Lot Number 001-120, and Serial Numbers ranging from SN110C30C580010802 to SN110C30C581200802. Consumers who have received this device should contact the manufacturer or their healthcare provider regarding the labeling deficiencies.
The recalled product
- Product
- AcoSound. Model Number: LW12-BTE-M
- Manufacturer
- HANGZHOU ACOSOUND TECHNOLOGY CO., LTD.
- Category
- Medical Device — Hearing Aid
- Hazard
- labeling-error
- udi-non-compliance
- mis-attribution
Distribution
Distributed nationwide across the United States.
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