International safety notice

Implantes cardíacos y vasculares BioIntegral Surgical No-React®: No-React® BioConduit (NRAC), No-React® BioPulmonic Conduit (NRPC), No-React® Injectable BioPulmonic (NRIP), No-React® BioMitral (NRM), No-React® BioAortic (NRA)

Spain / AEMPS · ESP · Aug 11, 2022

Key facts

Title Implantes cardíacos y vasculares BioIntegral Surgical No-React®: No-React® BioConduit (NRAC), No-React® BioPulmonic Conduit (NRPC), No-React® Injectable BioPulmonic (NRIP), No-React® BioMitral (NRM), No-React® BioAortic (NRA)
Regulator Spain / AEMPS
Country ESP
Brand Implantes cardíacos y vasculares BioIntegral Surgical No-React®: No-React® BioConduit (NRAC), No-React® BioPulmonic Conduit (NRPC), No-React® Injectable BioPulmonic (NRIP), No-React® BioMitral (NRM), No-React® BioAortic (NRA)
Manufacturer BioIntegral Surgical, Inc. Canada.
Models 91.822.52.89, NR200830, 79521, 2022-389, 28022, 31012, 2022-04-13, NR201115
Event type Safety Notice
Date Aug 11, 2022

At a glance

  • No Recall
  • Yes Field safety notice
  • 10–99 Matching device models in FDA data
  • 10–99 Matching catalog numbers in FDA data

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About International device safety notices

Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.

Source: National medical device regulators (as listed), compiled by Orca1

Browse all International device safety notices