Device recall

Z-0624-2016: NIPRO SET / SLIMLINE BLOOD TUBING SET for Hemodialysis with Transducer…

FDA device recall · Class II · Nipro Medical Corporation

Key facts

Recall number (Z-number) Z-0624-2016
Recall event 72701
Product NIPRO SET / SLIMLINE BLOOD TUBING SET for Hemodialysis with Transducer Protectors and Priming Set A disposable bloodline intended to provide extracorporeal access to the patient's blood during Hemodialysis. Compatible for use with Fresenius 2008H, 2008K/K2 and 2008T dialysis machines.
Product code FJK
Recalling firm Nipro Medical Corporation
Recall class Class II
Status Terminated
Termination date Feb 4, 2016
510(k) numbers K112628
FEI number 1000132332

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 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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