Medical Device Recall: Z-0008-05

FDA Recalls dataset · Firm: N/A · Status: Terminated

Recall Action Class: N/A Date Initiated: 2004-09-01 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0008-05.

Recall Res Number
Z-0008-05
Recalling Firm / Manufacturer
N/A
FEI Number
2183870
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2004-09-01
Date Posted
2004-10-05
Date Terminated
2005-11-03
Product Code
FGE
Event Number
29996
Product Quantity
5 systems
Product Description Biliary Stent System (6Fr 9mm x 30mm).
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.
Action Details A recall notification letter dated September 01, 2004 was sent to customers. Customers are to retain product until pick up by Ev3 sales representatives.
Distribution Pattern South Carolina, North Carolina, and Texas.
Code Information / Serial Numbers SERB65-09-30-120 (.035) (Biliary) LOT #: 257441

Related Establishments / Registrations

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