Recall Z-0624-2016— Nipro Medical Corporation

Name: FDA recall Z-0624-2016
Creator: U.S. Food and Drug Administration
Published: 2015-03-30

Class II · Terminated

Class II FDA medical device recall by Nipro Medical Corporation, initiated 2015-03-30, terminated 2016-02-04. It names one FDA 510(k) clearance: K112628. 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.. Reason: Blood foaming was found during evaluation of the product..

Recalling firm: Nipro Medical Corporation
Classification: Class II
Status: Terminated
Initiated: 2015-03-30
Terminated: 2016-02-04
Firm location: Miami, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K112628 — NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SETNipro Medical Corporation·cleared 2012-09-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

Blood foaming was found during evaluation of the product.

Data sourced from openFDA. This site is unofficial and independent of the FDA.