Device recall

Z-2589-2017: CADD High Volume Administration Set with FlowStop, 21-7381-24. Product Usage…

FDA device recall · Class II · Smiths Medical ASD Inc.

Key facts

Recall number (Z-number) Z-2589-2017
Recall event 77284
Product CADD High Volume Administration Set with FlowStop, 21-7381-24. Product Usage: The CADD High-Volume Administration set is designed for use with the CADD Prizm pump to allow fluid deliver from an IV bag.
Product code FPA
Recalling firm Smiths Medical ASD Inc.
Recall class Class II
Status Terminated
Termination date Apr 4, 2018
510(k) numbers K031361
FEI number 3012307300

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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