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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79750

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

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Event summary

Timeline bucket
February 15, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Transonic Systems Inc

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

Transonic ADT1018 Flow QC Clear Advantage Tubing, Catalog No. ADT1018, ADT1018-40 The device is indicated for use as part of an extracorporeal blood circuit for hemodialysis when a monitor will be used to make access flow, recirculation, and/or cardiac output measurements during the patient s hemodialysis treatment.

Z-1776-2018
Recall number
Z-1776-2018
Initiated
February 15, 2018
Classification
Class II
Status
Terminated
Recalling firm
Transonic Systems Inc
Quantity
6044

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The sterility of the device cannot be assured. There is a potential for an increased risk of infection.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The sterility of the device cannot be assured. There is a potential for an increased risk of infection.

Code information

Lots B151130E2 and B161115E0

Distribution pattern

Worldwide Distribution - USA (nationwide) Distribution and to the states of : NJ, NY, OH, PA, and TX., and to the countries of : Canada, South Korea, Thailand, Australia and Taiwan.