RegWardenFDA facility compliance records
Recall

Class II — Nipro Medical Corporation

Recalling firmNIPRO CORPORATION
Registered facilityView this company's 8 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonThere is a possibility of the heparin line is occluded.
ProductNipro 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.
Quantity307,944 units.
DistributionUS Distribution to the states of : GA, NY, TN, TX.
Initiated2017-12-19
Classified2018-05-15
Terminated2021-10-19
Recall numberZ-1876-2018
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Nipro Medical Corporation (Z-1876-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79834/

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