Recall Z-1876-2018— Nipro Medical Corporation

Name: FDA recall Z-1876-2018
Creator: U.S. Food and Drug Administration
Published: 2017-12-19

Class II · Terminated

Class II FDA medical device recall by Nipro Medical Corporation, initiated 2017-12-19, terminated 2021-10-19. It names one FDA 510(k) clearance: K072024. Product: Nipro Blood Tubing set with Priming Set and Transducer Protectors. Each device is packaged in a film pouch with 24 lines per case. The Nipro¿ Set - Blood Tubing Set with Transducer Protector and Priming Set are disposable bloodlines intended to provide extracorporeal access to the patient s blood during hemodialysis. The compatibility of available configurations is the responsibility of the physician in charge.. Reason: There is a possibility of the heparin line is occluded..

Recalling firm: Nipro Medical Corporation
Classification: Class II
Status: Terminated
Initiated: 2017-12-19
Terminated: 2021-10-19
Firm location: Doral, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K072024 — NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, MODEL A201-A219, V801-V806, 5M9634, 5M9693Nipro Medical Corp.·cleared 2007-10-04

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 Blood Tubing set with Priming Set and Transducer Protectors. Each device is packaged in a film pouch with 24 lines per case. The Nipro¿ Set - Blood Tubing Set with Transducer Protector and Priming Set are disposable bloodlines intended to provide extracorporeal access to the patient s blood during hemodialysis. The compatibility of available configurations is the responsibility of the physician in charge.

Reason for recall

There is a possibility of the heparin line is occluded.

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