Device recall

Z-3158-2011: Cook Medical Zenith Flex AAA Main Body Extension, REF ESBE-32-39, REF G32184, 20…

FDA device recall · Class III · Cook, Inc.

Key facts

Recall number (Z-number) Z-3158-2011
Recall event 58613
Product Cook Medical Zenith Flex AAA Main Body Extension, REF ESBE-32-39, REF G32184, 20 Fr. ID/ 7.7 mm OD, Sterile.
Product code MIH
Recalling firm Cook, Inc.
Recall class Class III
Status Terminated
Termination date Sep 13, 2011
PMA numbers P020018
FEI number 1820334

At a glance

  • None Linked 510(k)s
  • 10–99 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)