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Terminated

Biliary Stent System (6Fr 9mm x 30mm).

FDA Recall Z-0008-05 · Posted 2004-10-05

Recalling FirmEv3
Recall StatusTerminated
Product CodeFGE
Date Initiated2004-09-01
Date Terminated2005-11-03
Product Quantity5 systems

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.

Firm Action

A recall notification letter dated September 01, 2004 was sent to customers. Customers are to retain product until pick up by Ev3 sales representatives.

Root Cause

Other

Distribution Pattern

South Carolina, North Carolina, and Texas.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K033314PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEMEv3, Inc. · 2003-11-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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