Biliary Stent System (6Fr 9mm x 30mm). Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Biliary Stent System (6Fr 9mm x 30mm).
Lot Codes / Batch Numbers
SERB65-09-30-120 (.035) (Biliary) LOT #: 257441
Products Sold
SERB65-09-30-120 (.035) (Biliary) LOT #: 257441
A medical device manufacturer is recalling Biliary Stent System (6Fr 9mm x 30mm). due to 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 Sten. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
A recall notification letter dated September 01, 2004 was sent to customers. Customers are to retain product until pick up by Ev3 sales representatives.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
NC, SC, TX
Page updated: Jan 10, 2026