Recall Z-0007-2013— Invuity, Inc.
Class II · Terminated
Class II FDA medical device recall by Invuity, Inc., initiated 2012-05-12, terminated 2013-04-23. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. 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..
- Recalling firm
- Invuity, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-05-12
- Terminated
- 2013-04-23
- Firm location
- San Francisco, CA, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.