Reported Jun 9, 2021 · Ongoing
NexSite HD, Hemodialysis Symmetric Tip Catheter for long term use
Marvao Medical Devices Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: MARVAO MEDICAL DEVICES LTD. · Unit 1 Galway Business Park · Galway · N/A
Is this the product you have?
- NexSite HD, Hemodialysis Symmetric Tip Catheter for long term use
- Lot codes and dates
4 of 4 products
Products covered by this recall # Product as published 1 Model Number/Product Description/Lot Number: NEXHDSY1551901/NexSite HD Symmetric Tip Catheter 19cm/51377 2 NEXHDSY1552301/NexSite HD Symmetric Tip Catheter 23cm/51378 3 NEXHDSY1555501/NexSite HD Symmetric Tip Catheter 55cm/51380 4 NEXHDSY1552701/NexSite HD Symmetric Tip Catheter 27cm/51435 - Amount recalled
- 292 devices
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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