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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87827

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
February 11, 2020
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
MARVAO MEDICAL DEVICES LTD.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

NexSite HD, Hemodialysis Symmetric Tip Catheter for long term use

Z-1699-2021
Recall number
Z-1699-2021
Initiated
February 11, 2020
Classification
Class II
Status
Ongoing
Quantity
292 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The action is to ensure consistency between the Directions for Use (DFU) in the field and the DFU on the website.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The action is to ensure consistency between the Directions for Use (DFU) in the field and the DFU on the website.

Code information

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;

Distribution pattern

U.S.: CO, NC, SC, TX, O.U.S.: Not provided