Recall Z-0007-2013
Invuity, Inc. · initiated May 12, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Catalog numbers: 1810000, 1811273, 1811873, 1810873, 18111073 All possible lot numbers: 8Fr: 09061802, 09070201, 09070201, 09101602, 09120701, 10022602, 10030801, 10060102; 10Fr: 09061801, 09070202, 09120702, 09101603, 10022603, 10030802, 10060905, 10060904, 10060103; 12Fr: 09052901, 09061201, 09120703, 09101604, 10022604, 10030803, 10060104.
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.
FDA-determined cause: Other
Action taken
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.
Details
- Recall number
- Z-0007-2013
- Initiated
- May 12, 2012
- Posted by FDA
- October 3, 2012
- Terminated
- April 23, 2013
- Product code
- JOL – Catheter And Tip, Suction
- Quantity
- 197 devices
- Distribution
- Nationwide Distribution including AR, GA, SC, CA, OR, UT, and WA.
- Recalling firm
- Invuity, Inc., San Francisco, CA