Device recall

Z-1333-2011: Winged Infusion Set with 90 degree Huber Needle and Y Injection Site Distributed…

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

Key facts

Recall number (Z-number) Z-1333-2011
Recall event 57295
Product Winged Infusion Set with 90 degree Huber Needle and Y Injection Site Distributed By: FloridaInfustion Services, Inc., Palm Harbor, FL 34683 Item # FIY-2210 Intended use: Intravascular Administration Set
Product code FPA
Recalling firm Churchill Medical Systems, Inc.
Recall class Class II
Status Terminated
Termination date May 1, 2012
510(k) numbers K020544
FEI number 1000120555

At a glance

  • 1–9 Linked 510(k)s
  • 10–99 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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