Z-0094-2019 Class II Terminated
FDA device recall Z-0094-2019 was initiated by Widex A/S on August 31, 2018 and is designated Class II. Reason for recall: The reason for this field action is due to the mounting of a non-tamper-resistant (ordinary) battery drawer on some BABY440 hearing aids. The correct battery drawer is tamper-resistant and require a … The recall status is terminated (terminated December 21, 2018). Affected quantity: 2.
Recall Details
- Product Type
- Devices
- Report Date
- October 17, 2018
- Initiation Date
- August 31, 2018
- Termination Date
- December 21, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2
Product Description
Widex BABY hearing aid (referred to as BABY440), powered by zinc-air batteries size 10 Intended use: BABY440 is intended for, but not limited to, babies (0 to 3 years of age) to be used as air conduction amplification devices in everyday listening environments.
Reason for Recall
The reason for this field action is due to the mounting of a non-tamper-resistant (ordinary) battery drawer on some BABY440 hearing aids. The correct battery drawer is tamper-resistant and require a special tool to open it.
Distribution Pattern
US Distribution to states of: GA and NY.
Code Information
Serial numbers 024569 and 024550