| | Class 2 Recall
BriteField illuminated Suction Device |  |
| Date Posted |
October 03, 2012 |
| Recall Number |
Z-0007-2013 |
| 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. |
| Code Information |
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.
|
Recalling Firm/
Manufacturer |
Invuity, Inc.
39 Stillman St
San Francisco, California 94107-1309 |
| For Additional Information Contact |
Theresa Brandner-Allen
415-655-2100
|
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.
|
| 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 in Commerce |
197 devices |
| Distribution |
Nationwide Distribution including AR, GA, SC, CA, OR, UT, and WA. |
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