Enforcement Report - Week of October 10, 2012
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Product Detail
| 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. |
|---|---|
| Recall Number | Z-0007-2013 |
| Classification | Class II |
| Code Info | 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. |
| Product Distributed Qty | 197 devices |
| 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. |
Event Detail
| Event Id | 62966 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Invuity, Inc. |
| City | San Francisco |
| State | CA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-05-12 |
| Initial Firm Notification of Consignee or Public | |
| Distribution Pattern | Nationwide Distribution including AR, GA, SC, CA, OR, UT, and WA. |
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