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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79000

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

Open FDA event record

Event summary

Timeline bucket
December 19, 2017
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
LivaNova USA

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

Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L, Single Use, Sterile, Rx. The firm name on the label is Sorin Group USA, Inc., Arvada, CO.

Z-0664-2018
Recall number
Z-0664-2018
Initiated
December 19, 2017
Classification
Class III
Status
Terminated
Recalling firm
LivaNova USA
Quantity
16 units (6 from lot 1717800062 and 10 units from lot 1720800071

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The product is labeled with the incorrect expiration date.

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 product is labeled with the incorrect expiration date.

Code information

Lot 1717800062, UDI (01)00803622108075(240)088511400(17)190630(10)1717800082; and Lot 1720800071, UDI (01)00803622108075(240)088511400(17)190731(10)1720800071

Distribution pattern

Distribution was made to one consignee in LA.