Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Protg Self-Expanding Nitinol Stent 6 mm x 40 mm, Model Number SER6-6-40-135

FDA Recall Z-0863-03 · Posted 2003-05-22

Recalling Firmev3, Inc.
Recall StatusTerminated
Product CodeFGE
Date Initiated2003-04-15
Date Terminated2004-07-02
Product Quantity15 units

Reason for Recall

The label had an expiration date of August 2005, but the correct expiration date was February 2005.

Firm Action

A Device Recall letter dated April 15, 2003 requested that the consignees hold the product for retrieval by the firm's representatives.

Root Cause

Other

Distribution Pattern

Nationwide in United States.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K023243MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGYSulzer Intratherapeutics, Inc. · 2002-12-13

Official Source

View FDA Recall →

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

↑