Device recall

Z-2251-2013: Vygon 14 Microbore Extension Set with Bionector, CMS-814-1. The CMS-814-1 is a…

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

Key facts

Recall number (Z-number) Z-2251-2013
Recall event 66060
Product Vygon 14 Microbore Extension Set with Bionector, CMS-814-1. The CMS-814-1 is a 14 inch extension set used to administer IV fluids.
Product code FPA
Recalling firm Churchill Medical Systems, Inc.
Recall class Class II
Status Terminated
Termination date Jun 16, 2014
510(k) numbers K963981
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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