Nipro Blood Tubing set with Priming Set and Transducer Protectors. Each device is packaged in a ...
FDA Recall #Z-1876-2018 — Class II — December 19, 2017
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.
Recalling Firm
Nipro Medical Corporation — Doral, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
307,944 units.
Distribution
US Distribution to the states of : GA, NY, TN, TX.
Code Information
Model No. BL+A223D/V809D, Vendor Batch No. 17I06-9, 17I16-9, 17I18-9, 17J17-9, 17J19-9 , 17J20-9 , 17J21-9, 17I19-9, 17K07-9 , 17I01-9, 17J12-9, 17J16-9, 17I21-9, 17I25-9, 17I26-9, 17J09-9, 17J11-9, 17K15-9, 17K16-9.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated