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

Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 16 mm - usable length 88mm - delivery system 14 FR; Catalog no. TFLE-16-88.

FDA Recall Z-1195-04 · Posted 2004-07-27

Recalling FirmCook, Inc.
Recall StatusTerminated
Product CodeMIH
Date Initiated2004-06-10
Date Terminated2004-11-01
Product Quantity38

Reason for Recall

Introducer tubing may contain a vein of unextruded material and carbon black or a strand of tubing material may be displaced from the introducer during use.

Firm Action

The firm issued recall letters to customers on 6/10/04. The recall was extended and URGENT EXTENSION OF PRODUCT RECALL notices were sent out on June 23, 2004.

Root Cause

Other

Distribution Pattern

Nationwide, Canada, Denmark and Japan.

Official Source

View FDA Recall →

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

↑