Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall NeoMedix Trabectome I/A

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall NeoMedix Trabectome I/Asee related information
Date Initiated by FirmMay 28, 2007
Date PostedSeptember 29, 2008
Recall Status1 Terminated 3 on September 29, 2008
Recall NumberZ-0071-2008
Recall Event ID 48721
510(K)NumberK040239 
Product Classification surgical aspirator - Product Code BTA
ProductNeoMedix Trabectome I/A Console, Model Number 550014, surgical aspirator
Code Information Model Number 550014; Lot Number 061205-1; Serial Numbers: 10117, 10119, 10120, 10122, 10124, 100129, and 10133.
FEI Number 3003698071
Recalling Firm/
Manufacturer		 Neomedix Corp
15042 Parkway Loop Ste A
Tustin CA 92780-6528
For Additional Information Contact
949-258-8355
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn 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 Commerce7
DistributionNationwide to: CA, HI, IA, NY & PA
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = BTA
-
-