Medical device recalls Moderate risk

MARVAO MEDICAL DEVICES LTD. recalls NexSite HD, Hemodialysis Symmetric Tip Catheter for long term use

Recall date
February 11, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1699-2021
FDA classification
Class II
Brand / firm
MARVAO MEDICAL DEVICES LTD.
Sold / distributed
U.S.: CO, NC, SC, TX, O.U.S.: Not provided

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

NexSite HD, Hemodialysis Symmetric Tip Catheter for long term use

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