Z-0071-2008

NeoMedix Trabectome I/A Console, Model Number 550014, surgical aspirator

Name: Z-0071-2008 NeoMedix Trabectome I/A Console, Model Number 550014, surgical aspirator
Creator: Neomedix Corp
Published: 2007-05-28
License: https://open.fda.gov/license/

Neomedix Corp. / initiated 2007-05-28 / Terminated / root cause: manufacturing process

FDA source

Neomedix Corp began a recall of NeoMedix Trabectome I/A Console, Model Number 550014, surgical aspirator on 2007-05-28. The reason FDA records is "Failure of irrigation flow: The pinch valve in a few pumps may not consistently open to allow irrigation flow. In over 450 surgeries, the firm confirmed one instance of a valve that did not open. The electrically...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0071-2008
Status: Terminated
Initiated: 2007-05-28
Posted: 2008-09-29
Terminated: 2008-09-29
Recalling firm: Neomedix Corp.
Product: NeoMedix Trabectome I/A Console, Model Number 550014, surgical aspirator
Product code: BTA Pump, Portable, Aspiration (Manual Or Powered)
Reason for recall: Failure of irrigation flow: The pinch valve in a few pumps may not consistently open to allow irrigation flow. In over 450 surgeries, the firm confirmed one instance of a valve that did not open. The electrically activated pinch valve in the NeoMedix Trabectome I/A pump activates irrigation flow to the eye during Trabectome surgery.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On May 31, 2007 NeoMedix mailed a Customer letter to all consignees informing them of the hazard. The letter also indicated to the customers they NeoMedix has developed a minor modification/upgrade that is designed to assure that the pinch valve opens at the appropriate time. The customers were instructed this modification requires return of their existing pump for modification and testing at the firm's facility before its return. In the event that surgeries have already been scheduled, NeoMedix will provide a loaner unit until the suspect unit can be modified and returned to you. The letter also indicated the cost of the modification and/or use of a loaner unit will be entirely at NeoMedix expense. You will be contacted to establish the details of implementing this modification.
Quantity in commerce: 7
Distribution: Nationwide to: CA, HI, IA, NY & PA
Product codes and lots: Model Number 550014; Lot Number 061205-1; Serial Numbers: 10117, 10119, 10120, 10122, 10124, 100129, and 10133.

Product code BTA

K040239Class IISupraflow ConsoleNeomedix Corp. / cleared 2004-02-17

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)