Medical device recalls Moderate risk

Nipro Medical Corporation recalls NIPRO SET / SLIMLINE BLOOD TUBING SET for Hemodialysis with Transducer Protectors and Priming Set A disposable bloodlin…

Recall date
March 30, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0624-2016
FDA classification
Class II
Brand / firm
Nipro Medical Corporation
Sold / distributed
US Distribution to states of: TN and NJ.

Why it was recalled

Blood foaming was found during evaluation of the product.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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