Class II — MARVAO MEDICAL DEVICES LTD.
| Recalling firm | Marvao Medical Devices Ltd. |
|---|---|
| Registered facility | MARVAO MEDICAL DEVICES LTD. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | The action is to ensure consistency between the Directions for Use (DFU) in the field and the DFU on the website. |
| Product | NexSite HD, Hemodialysis Symmetric Tip Catheter for long term use |
| Quantity | 292 devices |
| Distribution | U.S.: CO, NC, SC, TX, O.U.S.: Not provided |
| Initiated | 2020-02-11 |
| Classified | 2021-06-01 |
| Recall number | Z-1699-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — MARVAO MEDICAL DEVICES LTD. (Z-1699-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87827/
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