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U.S. Department of Health and Human Services

Enforcement Report - Week of October 10, 2012

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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
E-Mail
Distribution Pattern Nationwide Distribution including AR, GA, SC, CA, OR, UT, and WA.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. 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. Class II 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. 197 devices Z-0007-2013
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