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Terminated

Primus Biliary Stent and Delivery System. Balloon Expandable Stent and Delivery System. Rx only. Model BXB35-07-27-75

FDA Recall Z-0442-06 · Posted 2006-01-25

Recalling FirmEv3, Inc
Recall StatusTerminated
Product CodeFGE
Date Initiated2005-08-01
Date Terminated2006-12-31
Product Quantity18 devices

Reason for Recall

A Primus device was labeled as a BXB 35 09-37-75 but contained a BXB35 07-27-75 stent.

Firm Action

Notification was sent to ev3 Territory Managers to have them contact their customer, have them remove affected product from their shelves and place them aside. TheTerritory Manager is responsible for retreiving affected product and returning it to ev3.

Root Cause

Other

Distribution Pattern

AL, AZ, FL, KS, LA, MS, NC, NE, NY, TX

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K043243PRIMUS STENT AND DELIVERY SYSTEMEv3, Inc. · 2004-12-09

Official Source

View FDA Recall →

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

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