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U.S. Department of Health and Human Services

Class 2 Device Recall BriteField illuminated Suction Device

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 Class 2 Recall
BriteField illuminated Suction Device
see related information
Date Posted October 03, 2012
Recall Status1 Terminated on April 23, 2013
Recall Number Z-0007-2013
Recall Event ID 62966
Product Classification Catheter And Tip, Suction - Product Code JOL
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
Manufacturer 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 2
OTHER/UNDETERMINED: Pending
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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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