Device recall

Z-1219-04: Cook brand Zenith rupture main body graft, preloaded graft measuring 26 mm…

FDA device recall · Class II · Cook, Inc.

Key facts

Recall number (Z-number) Z-1219-04
Recall event 29300
Product Cook brand Zenith rupture main body graft, preloaded graft measuring 26 mm diameter at promial end and 12 mm diameter at distal end, with the H&L-B One Shot Introducer System, non-sterile, export only for further processing; ZRB-26-WCE.
Product code MIH
Recalling firm Cook, Inc.
Recall class Class II
Status Terminated
Termination date Nov 1, 2004
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

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