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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85494

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

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Event summary

Timeline bucket
June 01, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Centurion Medical Products Corporation

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

Centurion DIFFICULT IV KIT containing BD's Vacutainer Plastic Lithium Heparin Tubes (BD Vacutainer-BD Codes 367884 & 367960; Centurion code 45177 (VACUTAINER GREEN TOP) and 84815 (VACUTAINER 3ML LT. GREEN). Centurion Kit Code: IV8860

Z-2545-2020
Recall number
Z-2545-2020
Initiated
June 01, 2019
Classification
Class II
Status
Terminated
Quantity
140 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
False elevation of carboxyhemoglobin (COHb) results in blood samples collected using BD Vacutainer¿ Plastic Lithium Heparin tubes with the IL GEM 4000 instrument.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

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Inspect official wording and provenance

Reason for recall

False elevation of carboxyhemoglobin (COHb) results in blood samples collected using BD Vacutainer¿ Plastic Lithium Heparin tubes with the IL GEM 4000 instrument.

Code information

Lot Number: 2019050790 exp. Date: 10/31/2019

Distribution pattern

US Nationwide distribution including in the state of IL.