Reported Oct 10, 2012 · Terminated
BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a…
Invuity, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Invuity, Inc. · 39 Stillman St · San Francisco, CA · 94107-1309
Is this the product you have?
- 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.
- Lot codes and dates
- Catalog numbers
181000018112731811873181087318111073
- All possible lot numbers
8Fr: 090618020907020109070201091016020912070110022602100308011006010210Fr: 09061801090702020912070209101603100226031003080210060905100609041006010312Fr: 09052901090612010912070309101604100226041003080310060104
- Catalog numbers
- Amount recalled
- 197 devices
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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