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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84880

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

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Event summary

Timeline bucket
January 30, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Organ Recovery 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

LKT200 Perfusion Circuit, part of Lifeport Kidney Perfusion Transporter KTR - Product Usage: The circuit is an accessory to LifePort Kidney Perfusion Transporter (KTR) Isolated kidney perfusion and transport system, which is intended to be used for the continuous hypothermic machine perfusion of kidneys for the preservation, transportation and eventual transplantation into a recipient.

Z-1437-2020
Recall number
Z-1437-2020
Initiated
January 30, 2020
Classification
Class II
Status
Terminated
Quantity
2274

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Observed leakage at the sample port assembly which could potentially lead to loss of perfusion solution needed to maintain continuous machine perfusion.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Reprocessing Controls

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Inspect official wording and provenance

Reason for recall

Observed leakage at the sample port assembly which could potentially lead to loss of perfusion solution needed to maintain continuous machine perfusion.

Code information

LKT2000 Lots 119944, 119765, 119648, 120055, 120242.

Distribution pattern

Distributed nationwide (32 states) and to Canada.