Recall Z-2348-2008
Acacia Engineered Products LLC · initiated July 9, 2008
Product
Isotechnology, Isobalance System; Serial Numbers: 07-030. The product was being investigated as a device to determine possible inner ear problems.
Codes / lots: Serial numbers: 07-001 through 07-030.
Reason for recall
The firm distributed an unapproved medical device.
FDA-determined cause: PMA
Action taken
On July 9, 2008 the firm issued a Device Recall Notification letter to its consignees by letter on July 9, 2008 by US mail. The recall notification was directed to the end users of the units requesting the return of all units. In the event of a non-responding consignee, the firm will make additional efforts to contact the individual via certified return receipt mail or other form of notification requiring a signature. Follow up direct contact through telephone will also be used. If you have any questions contact Eric Johnson at (615) 202-9370.
Details
- Recall number
- Z-2348-2008
- Initiated
- July 9, 2008
- Posted by FDA
- September 17, 2008
- Terminated
- February 17, 2010
- Product code
- LXV – Apparatus, Vestibular Analysis
- Quantity
- 24
- Distribution
- Class II Recall - Nationwide Distribution --- including states of CA, VA, MA and TX.
- Recalling firm
- Acacia Engineered Products LLC, Franklin, TN