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Terminated

Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 32mm, B=155mm, C=125mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-32-125.

FDA Recall Z-0521-05 · Posted 2005-02-03

Recalling FirmCook, Inc.
Recall StatusTerminated
Product CodeMIH
Date Initiated2004-12-20
Date Terminated2005-12-02

Reason for Recall

The firm has received complaints of difficulty in releasing the barbed suprarenal stent from the top cap that constrains it, which may result in misplacement of the graft.

Firm Action

Recall letter dated 12/20/04 was issued to each consignee via FedEx instructing them to cease using the products and to return them to the firm.

Root Cause

Other

Distribution Pattern

Nationwide and Canada.

Official Source

View FDA Recall →

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

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