Device recall

Z-1254-2012: Universal drainage kit, catalog# 900-032

FDA device recall · Class II · Customed, Inc

Key facts

Recall number (Z-number) Z-1254-2012
Recall event 60753
Product Universal drainage kit, catalog# 900-032
Product code FCM
Recalling firm Customed, Inc
Recall class Class II
Status Terminated
Termination date Apr 12, 2017
510(k) numbers K961442
FEI number 2648727

At a glance

  • 1–9 Linked 510(k)s
  • 10–99 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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