Device recall

Z-1177-2008: CalMed Malleable Pericardial Sump, Single Use Only. Do Not Reuse. REF SU-20802…

FDA device recall · Class II · California Medical Laboratories Inc

Key facts

Recall number (Z-number) Z-1177-2008
Recall event 46745
Product CalMed Malleable Pericardial Sump, Single Use Only. Do Not Reuse. REF SU-20802; CalMed Laboratories, Costa Mesa, CA 92626
Product code DTS
Recalling firm California Medical Laboratories Inc
Recall class Class II
Status Terminated
Termination date Mar 5, 2013
510(k) numbers K982891
FEI number 1000135553

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

Browse all FDA device recalls (products)