Device recall

Z-0914-2013: Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010 Huber type needle set…

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

Key facts

Recall number (Z-number) Z-0914-2013
Recall event 64464
Product Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010 Huber type needle set used for the infusion of medical fluids into implantable ports.
Product code FPA
Recalling firm Churchill Medical Systems, Inc.
Recall class Class II
Status Terminated
Termination date Sep 10, 2013
510(k) numbers K013871
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

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