Device recall

Z-0740-2013: Cordis, a Johnson and Johnson Company, ExoSeal(TM) 6F Vascular Closure Device…

FDA device recall · Class II · Cordis Corporation

Key facts

Recall number (Z-number) Z-0740-2013
Recall event 63827
Product Cordis, a Johnson and Johnson Company, ExoSeal(TM) 6F Vascular Closure Device, cat. No EX500, EX600, and EX700. Used for femoral artery puncture site closure, reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional procedures.
Product code MGB
Recalling firm Cordis Corporation
Recall class Class II
Status Terminated
Termination date Nov 6, 2013
PMA numbers P100013
FEI number 1016427

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 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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