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Terminated

Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-20-56-ZT, REF G48477, 16Fr ID/ 6.0 mm OD, Sterile.

FDA Recall Z-3153-2011 · Posted 2011-09-06

Recalling FirmCook, Inc.
Recall StatusTerminated
Product CodeMIH
Date Initiated2011-04-15
Date Terminated2011-09-13
Product Quantity2 units

Reason for Recall

The firm initiated this action in response to information that there may be potential damage in the braided suture which is used to attach the external stents to the graft material.

Firm Action

The firm sent URGENT PRODUCT RECALL notices dated 4/15/2011 to Risk Managers/Recall Administration (Chief of Vascular Surgery and or Interventional Radiology). The letters explained the problem with the devices and the action to be taken. Consignees were instructed to return the recalled devices to Cook Medical for credit or replacement. Customers with questions or concerns can contact the firm at 800-457-2235.

Root Cause

Process control

Distribution Pattern

US, Canada, Japan

Official Source

View FDA Recall →

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

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