Reported Oct 17, 2018 · Terminated
Widex BABY hearing aid (referred to as BABY440), powered by zinc-air batteries size 10 Intended use: BABY440 is…
Widex A/S
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Widex A/S · Nymollevej 6 · Lynge · N/A
Is this the product you have?
- Widex BABY hearing aid (referred to as BABY440), powered by
- zinc-air batteries size 10 Intended useBABY440 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
- Lot codes and dates
- Serial numbers 024569 and 024550
- Amount recalled
- 2
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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