Cook Medical Zenith Flex AAA Main Body Extension, REF ESBE-32-39, REF G32184, 20 Fr. ID/ 7.7 mm OD, Sterile.

FDA device recall Z-3158-2011 · posted 2011-09-06 · Terminated

Recall details

Recalling firm

Cook, Inc.

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.

Action taken

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

Status

Terminated

Product code

MIH

Quantity affected

1 unit

Distribution

US, Canada, Japan

Date initiated

2011-04-15

Date posted

2011-09-06

Date terminated

2011-09-13

Location

Bloomington, IN