Device recall

Z-0557-2009: Femoral Compression Device Model #'s: RAD11163 Intended for use in the…

FDA device recall · Class II · Sterilmed Inc

Key facts

Recall number (Z-number) Z-0557-2009
Recall event 49510
Product Femoral Compression Device Model #'s: RAD11163 Intended for use in the compression of the femoral artery or vein after cauterization.
Product code NMF
Recalling firm Sterilmed Inc
Recall class Class II
Status Terminated
Termination date Apr 26, 2011
510(k) numbers K012574
FEI number 3001237663

At a glance

  • 1–9 Linked 510(k)s
  • 10–99 Products in the same recall event
  • 1–9 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)