Recall Z-1681-2010
InSound Medical, Inc. · initiated January 19, 2010
Product
InSound Medical, Inc, Lyric in-canal hearing aid.
Codes / lots: All devices manufactured between 12/10/2009 and 12/24/2009. Expiration dates 12/10/2010 through 12/24/2010.
Reason for recall
Manufacturing error could result in electrolyte leakage from the product's battery.
FDA-determined cause: Process design
Action taken
InSound sent to its consignees a "Dear Lyric Provider" letter of explanation on 2/1/2010.
Details
- Recall number
- Z-1681-2010
- Initiated
- January 19, 2010
- Posted by FDA
- May 26, 2010
- Terminated
- August 2, 2011
- Product code
- ESD – Hearing Aid, Air-Conduction, Prescription
- Quantity
- 2019 units
- Distribution
- Distribution only in US ( nationwide). No foreign consignees involved.
- Recalling firm
- InSound Medical, Inc., Newark, CA