Device recall

Z-0813-2014: AMS-530 7 Microbore Trifurcated Extension sets Product Usage: Intravascular…

FDA device recall · Class II · Churchill Medical Systems, Inc.

Key facts

Recall number (Z-number) Z-0813-2014
Recall event 67255
Product AMS-530 7 Microbore Trifurcated Extension sets Product Usage: Intravascular administration set.
Product code FPA
Recalling firm Churchill Medical Systems, Inc.
Recall class Class II
Status Terminated
Termination date Nov 3, 2014
510(k) numbers K021395
FEI number 1000120555

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1,000+ 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)