FDAClass IIJune 9, 2021

NexSite HD recall

NexSite HD, Hemodialysis Symmetric Tip Catheter for long term use

Why was NexSite HD recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model Number/Product Description/Lot Number: NEXHDSY1551901/NexSite HD Symmetric Tip Catheter 19cm/51377; NEXHDSY1552301/NexSite HD Symmetric Tip Catheter 23cm/51378; NEXHDSY1555501/NexSite HD Symmetric Tip Catheter 55cm/51380; NEXHDSY1552701/NexSite HD Symmetric Tip Catheter 27cm/51435;

Product
NexSite HD, Hemodialysis Symmetric Tip Catheter for long term use
Recalling firm
MARVAO MEDICAL DEVICES LTD.
Quantity
292 devices
Distribution
U.S.: CO, NC, SC, TX, O.U.S.: Not provided
Recall date
June 9, 2021
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls