Device recall

Z-0680-2018: CVC Tray Pediatrics. Product Code: AMS-9335CP-2.

FDA device recall · Class II · Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.

Key facts

Recall number (Z-number) Z-0680-2018
Recall event 78951
Product CVC Tray Pediatrics. Product Code: AMS-9335CP-2.
Product code LJS
Recalling firm Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
Recall class Class II
Status Terminated
Termination date Nov 7, 2019
510(k) numbers K954302
FEI number 1000120555

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

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