NexSite HD — Class II medical device recall Z-1699-2021
Ongoing recall by MARVAO MEDICAL DEVICES LTD., reported 2021-06-09, distributed in CO, NC, SC, TX. The action is to ensure consistency between the Directions for Use (DFU) in the field and the DFU on the websi
| Recall number | Z-1699-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MARVAO MEDICAL DEVICES LTD., Galway, Ireland |
| Recall initiated | 2020-02-11 |
| Classified | 2021-06-01 |
| Reported by FDA | 2021-06-09 |
| Distributed | CO, NC, SC, TX |
| Quantity | 292 devices |
| Lot numbers | NEXHDSY1551901/NEXSITEHD |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1699-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.