FDA-Device2016-01-20Class II

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.

Nipro Medical Corporation
Hazard

Blood foaming was found during evaluation of the product.

Sold states
US Distribution to states of: TN and NJ.
Affected count
1,484 pieces.
Manufactured in
3150 Nw 107th Ave, N/A, Miami, FL, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0624-2016

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