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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81598

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

Open FDA event record

Event summary

Timeline bucket
November 05, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Fresenius Medical Care Renal Therapies Group, LLC

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

Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E

Z-0658-2019
Recall number
Z-0658-2019
Initiated
November 05, 2018
Classification
Class II
Status
Terminated
Quantity
9,097 cs x 12 units each

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for external blood leaks from the dialyzer header

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for external blood leaks from the dialyzer header

Code information

Lot Numbers: 18HU06016, 18HU06017, 18HU06018 and 18HU06019

Distribution pattern

US Nationwide