FDA Device recall Z-1699-2021
NexSite HD, Hemodialysis Symmetric Tip Catheter for long term use
- FDA Device
- Class II
- ongoing
- Published 2021-06-09
On 2021-06-09 the FDA classified a Class II recall of NexSite HD, Hemodialysis Symmetric Tip Catheter for long term use by Marvao Medical Devices, citing the action is to ensure consistency between the Directions for Use (DFU) in the field and the DFU on the website.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1699-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-02-11 |
| Published | 2021-06-09 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Marvao Medical Devices |
| Distribution | CO, NC, SC, TX |
Product
NexSite HD, Hemodialysis Symmetric Tip Catheter for long term use
Reason
The action is to ensure consistency between the Directions for Use (DFU) in the field and the DFU on the website.
Identifiers
| code_info | Model Number/Product Description/Lot Number: NEXHDSY1551901/NexSite HD Symmetric Tip Catheter 19cm/51377; NEXHDSY1552…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; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1699-2021%22
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