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Terminated

Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System, preloaded bifurcated main body graft - aortic graft diameter 26 mm - iliac leg diameters 11 mm - main body length contralateral limb 132mm ipsilateral limb 133 mm - delivery system 18 FR; Catalog no. TFB-26-132.

FDA Recall Z-1173-04 · Posted 2004-07-27

Recalling FirmCook, Inc.
Recall StatusTerminated
Product CodeMIH
Date Initiated2004-06-10
Date Terminated2004-11-01
Product Quantity8

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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