Date Initiated by Firm |
January 19, 2010 |
Date Posted |
May 26, 2010 |
Recall Status1 |
Terminated 3 on August 02, 2011 |
Recall Number |
Z-1681-2010 |
Recall Event ID |
54473 |
510(K)Number |
K081136
|
Product Classification |
hearing aid - Product Code ESD
|
Product |
InSound Medical, Inc, Lyric in-canal hearing aid. |
Code Information |
All devices manufactured between 12/10/2009 and 12/24/2009. Expiration dates 12/10/2010 through 12/24/2010. |
Recalling Firm/ Manufacturer |
InSound Medical, Inc. 37500 Central Ct Newark CA 94560-3454
|
For Additional Information Contact |
510-792-4000 Ext. 470
|
Manufacturer Reason for Recall |
Manufacturing error could result in electrolyte leakage from the product's battery.
|
FDA Determined Cause 2 |
Process design |
Action |
InSound sent to its consignees a "Dear Lyric Provider" letter of explanation on 2/1/2010. |
Quantity in Commerce |
2019 units |
Distribution |
Distribution only in US ( nationwide). No foreign consignees involved. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = ESD and Original Applicant = INSOUND MEDICAL INC.
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