Device recall

Z-0402-2016: One Step Button, Low Profile Initial Placement PEG Kit, gastro-enterostomy tube.

FDA device recall · Class II · Boston Scientific Corp

Key facts

Recall number (Z-number) Z-0402-2016
Recall event 72364
Product One Step Button, Low Profile Initial Placement PEG Kit, gastro-enterostomy tube.
Product code KGC
Recalling firm Boston Scientific Corp
Recall class Class II
Status Terminated
Termination date May 17, 2016
510(k) numbers K910584
FEI number 1828132

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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