FDA recall Z-1699-2021

MARVAO MEDICAL DEVICES LTD. · Class II · device

Product

NexSite HD, Hemodialysis Symmetric Tip Catheter for long term use

Reason for recall

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

Distribution

U.S.: CO, NC, SC, TX, O.U.S.: Not provided

Key facts

Status
Ongoing
Initiation date
2020-02-11
Report date
2021-06-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Galway, Ireland

Primary source

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