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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84732

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

Open FDA event record

Event summary

Timeline bucket
July 03, 2019
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
LivaNova USA 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

LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected product is a perfusion tubing pack use in surgical procedures requiring extracorporeal support. The perfusion tubing packs include the cuvette used with equipment to monitor blood.

Z-1389-2020
Recall number
Z-1389-2020
Initiated
July 03, 2019
Classification
Class III
Status
Terminated
Recalling firm
LivaNova USA Inc.
Quantity
27 packs

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Perfusion tubing pack was packaged with the incorrect cuvette.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Perfusion tubing pack was packaged with the incorrect cuvette.

Code information

Model Number: 046008200 Lot Number: 1912100141 UDI: (01)00803622140136(240)046008200 (17)210430(10)1912100141 Cuvette Component P/N 03016 - SAT/HCT B-care 5 cuvette

Distribution pattern

US Nationwide distribution in the state of IL.