Device recall

Z-1166-06: CPS Direct SL, Models 410110, 410111, 410112, 410113, 410114, 410115, 410116…

FDA device recall · Class II · St Jude Medical CRMD

Key facts

Recall number (Z-number) Z-1166-06
Recall event 35616
Product CPS Direct SL, Models 410110, 410111, 410112, 410113, 410114, 410115, 410116, 410120, 410121, 410122, 410123, 410124, 410125, & 410126
Product code DQY
Recalling firm St Jude Medical CRMD
Recall class Class II
Status Terminated
Termination date Mar 26, 2012
510(k) numbers K053217
FEI number 2017865

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 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

Browse all FDA device recalls (products)