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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67797

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

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Event summary

Timeline bucket
December 09, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Gambro Renal Products, Incorporated

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

Gambro Cartridge Blood Set, blood transport system for hemodialysis, Model Number(s): 101025 (003410510) - Cartridge set, STND PRM LN and 103401 (003414500) - Cartridge set, PRM_LN_INJ_PT. The Gambro Cartridge Sets are single use sterile tubing sets intended to provide extracorporeal blood transport circuit for hemodialysis treatments for Gambro Phoenix and COBE Centrisystem 3 (and 3+) Dialysis Delivery Systems.

Z-1455-2014
Recall number
Z-1455-2014
Initiated
December 09, 2013
Classification
Class II
Status
Terminated
Quantity
306,525 sets (20435 boxes of 15 sets)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Occluded heparin tubing events preventing anticoagulation dosing on the Gambro Cartridge Blood Sets.

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

Occluded heparin tubing events preventing anticoagulation dosing on the Gambro Cartridge Blood Sets.

Code information

Lot number: 1000039228, 1000048340, 1000050644, 1000050648, 1000054032, 1000058516, 1000064913, 1000065817, 1000065823, 1000066430, 1000063347, 1000067984, 1000068071, 1000071417, 1000071430, 1000073434, 1000073436, 1000073438, 1000074660, 1000074661, 1000074662, 1000075553

Distribution pattern

Worldwide Distribution-USA (nationwide) and the countries of Canada, Mexico, and Colombia.