Device recall

Z-1128-2010: Y Type Blood Pump Sets, with 2 Vented Spikes and Double "Hi-Flo" Stopcock; with…

FDA device recall · Class I · Arrow International Inc

Key facts

Recall number (Z-number) Z-1128-2010
Recall event 54723
Product Y Type Blood Pump Sets, with 2 Vented Spikes and Double "Hi-Flo" Stopcock; with Luer Activated Y-Injection Sites, Y-Injection Site and 2 Gang 4-Way Stopcocks; with "Hi-Flo" Stopcocks and SmartSite(TM) Y Injection Site. SmartSite(TM) is a trademark of Alaris Medical Systems, Inc.; with Ball Pump…
Product code FPA
Recalling firm Arrow International Inc
Recall class Class I
Status Terminated
Termination date Nov 8, 2012
510(k) numbers K830755
FEI number 3015859709

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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