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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 75589

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

Open FDA event record

Event summary

Timeline bucket
November 03, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Terumo BCT, 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

Adiprep Adipose Transfer System. Product Codes: 51431; 51432; 51433; 514001-347.

Z-0674-2017
Recall number
Z-0674-2017
Initiated
November 03, 2016
Classification
Class II
Status
Terminated
Recalling firm
Terumo BCT, Inc.
Quantity
660

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incorrectly labeled

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Terumo BCT announces a voluntary field action for the Harvest : Adiprep Adipose Transfer System because the affected product is incorrectly labeled and has the potential for operator confusion.

Code information

Product Code: 51431, Lot Codes: 07Z9913; 07Z9933; 08Z9932; 09Z9908; 10Z9908 Product Code: 51432, Lot Codes: 08Z9907; 09Z9931. Product Code: 51433, Lot Codes: 08Z9901; 08Z9933. Product Code: 514001-347, Lot Codes: 05Z9956; 05Z9956; 07Z9917; 07Z9917; 07Z9917; 07Z9917; 05Z9956; 05Z9956; 07Z9917

Distribution pattern

Nationwide, Canadian, and other foreign consignees. No VA/govt/military consignees.

Field note

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