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 Protege GPS Biliary Stent System

  • 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 Protege GPS Biliary Stent Systemsee related information
Date Initiated by FirmSeptember 01, 2004
Date PostedOctober 05, 2004
Recall Status1 Terminated 3 on November 03, 2005
Recall NumberZ-0008-05
Recall Event ID 29996
510(K)NumberK033314 
Product Classification Stents, Drains And Dilators For The Biliary Ducts - Product Code FGE
ProductBiliary Stent System (6Fr 9mm x 30mm).
Code Information SERB65-09-30-120 (.035) (Biliary) LOT #: 257441
FEI Number 2183870
Recalling Firm/
Manufacturer		 Ev3
4600 Nathan Ln N
Plymouth MN 55442-2890
Manufacturer Reason
for Recall		A customer complaint received indicated that a Protg stent, PN SERB65-09-30-120 was found in a pouch that was not properly sealed. The Protg GPS Stent System is 'double barrier' packaged and consists of a sealed inner tray in a sealed pouch. The pouch seal ensures sterility of the external surface of the inner tray. The inner tray seal containing the device was not affected.
FDA Determined
Cause 2		Other
ActionA recall notification letter dated September 01, 2004 was sent to customers. Customers are to retain product until pick up by Ev3 sales representatives.
Quantity in Commerce5 systems
DistributionSouth Carolina, North Carolina, and Texas.
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 = FGE
-
-