Device recall

Z-0023-2009: Applied Medical, Separator Abdominal Access System REF: C0604 15 x 100mm…

FDA device recall · Class II · Applied Medical Resources Corp

Key facts

Recall number (Z-number) Z-0023-2009
Recall event 49445
Product Applied Medical, Separator Abdominal Access System REF: C0604 15 x 100mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.
Product code HET
Recalling firm Applied Medical Resources Corp
Recall class Class II
Status Terminated
Termination date Mar 26, 2012
510(k) numbers K012884, K945741
FEI number 2027111

At a glance

  • 1–9 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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