FDA-Device2021-06-09Class II

NexSite HD, Hemodialysis Symmetric Tip Catheter for long term use

MARVAO MEDICAL DEVICES LTD.
Hazard

The action is to ensure consistency between the Directions for Use (DFU) in the field and the DFU on the website.

Sold states
U.S.: CO, NC, SC, TX, O.U.S.: Not provided
Affected count
292 devices
Manufactured in
Unit 1 Galway Business Park, Dangan, Galway, Ireland
Products
NexSite HD, Hemodialysis Symmetric Tip Catheter for long term use

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1699-2021

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