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Terminated

Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 18 mm - usable length 54mm - delivery system 16 FR; Catalog no. TFLE-18-54.

FDA Recall Z-1197-04 · Posted 2004-07-27

Recalling FirmCook, Inc.
Recall StatusTerminated
Product CodeMIH
Date Initiated2004-06-10
Date Terminated2004-11-01
Product Quantity35

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.

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