RegWardenFDA facility compliance records
Recall

Class II — MARVAO MEDICAL DEVICES LTD.

Recalling firmMarvao Medical Devices Ltd.
Registered facilityMARVAO MEDICAL DEVICES LTD. (the firm's only registered facility)
ClassificationClass II
StatusOngoing
ReasonThe action is to ensure consistency between the Directions for Use (DFU) in the field and the DFU on the website.
ProductNexSite HD, Hemodialysis Symmetric Tip Catheter for long term use
Quantity292 devices
DistributionU.S.: CO, NC, SC, TX, O.U.S.: Not provided
Initiated2020-02-11
Classified2021-06-01
Recall numberZ-1699-2021
InitiationVoluntary: 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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