Recall Z-0071-2008 ยท BTA Pump, Portable, Aspiration (Manual Or Powered)
Neomedix Corp
NeoMedix Trabectome I/A Console, Model Number 550014, surgical aspirator
| Date | Sep 29, 2008 (initiated May 28, 2007) |
| Status | Terminated |
| Reason | 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 | 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 lette |
| Quantity | 7 |
| Distribution | Nationwide to: CA, HI, IA, NY & PA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040239 | SUPRAFLOW CONSOLE Neomedix Corp., Feb 17, 2004 |