Recall Z-0007-2013 ยท JOL Catheter And Tip, Suction
Invuity, Inc.
BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.
| Date | Oct 3, 2012 (initiated May 12, 2012) |
| Status | Terminated |
| Reason | Invuity is notifying customers to return all obsolete BriteField Illuminated Suction Devices from the field. It has not been distributed since March 2011 as the next generation product was introduced at that time. |
| Root cause | Other |
| Action | Invuity sent E-mails to those locations thought to still be in possession of the old model of the device in July 2012. Distributors had been e-mailed in May 2012 to make sure that they had returned any of the device that was in stock. For questions regarding this recall call 415-655-2100. |
| Quantity | 197 devices |
| Distribution | Nationwide Distribution including AR, GA, SC, CA, OR, UT, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.