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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90143

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

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Event summary

Timeline bucket
April 08, 2022
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
XVIVO PERFUSION AB

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

XVIVO Organ Chamber REF 19020

Z-1212-2022
Recall number
Z-1212-2022
Initiated
April 08, 2022
Classification
Class II
Status
Terminated
Recalling firm
XVIVO PERFUSION AB
Quantity
80 devices

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
seal of the primary pouch was incomplete, and the sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ensured/guaranteed.

Code information

Model Number: 19020 Lot Numbers/UDI Codes: LOT: 13801, UDI: (01)07350069520074(17)240930(10)13801 LOT: 13802, UDI: (01)07350069520074(17)240930(10)13802 LOT: 13803, UDI: (01)07350069520074(17)240930(10)13803 LOT: 13804, UDI: (01)07350069520074(17)240930(10)13804 LOT: 13805, UDI: (01)07350069520074(17)240930(10)13805 LOT: 13806, UDI: (01)07350069520074(17)240930(10)13806

Distribution pattern

U.S.: CA, FL, MA, NC, NY, OH, PA, and TX O.U.S.: Austria, Canada, France, Ireland, Italy, and the Netherland