Z-0007-2013Class II

BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and...

Name: Z-0007-2013 BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and...
Creator: Invuity, Inc.
Published: 2012-05-12
License: https://open.fda.gov/license/

Invuity, Inc. / initiated 2012-05-12 / Terminated

FDA source

Invuity, Inc. began a recall of BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field... on 2012-05-12. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0007-2013
Classification: Class II
Status: Terminated
Initiated: 2012-05-12
Posted: 2012-10-03
Terminated: 2013-04-23
Recalling firm: Invuity, Inc.
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.
Product code: JOL Catheter And Tip, Suction
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 root cause: Other
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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0007-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0007-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-10	2012-10-03

Product code JOL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)