FDA recall Z-1876-2018

Nipro Medical Corporation · Class II · device

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 for recall

There is a possibility of the heparin line is occluded.

Distribution

US Distribution to the states of : GA, NY, TN, TX.

Key facts

Status
Terminated
Initiation date
2017-12-19
Report date
2018-05-23
Termination date
2021-10-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Doral, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1876-2018