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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88267

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

Open FDA event record

Event summary

Timeline bucket
March 22, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
QURA S.R.L.

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

Spectrum Medical Quantum Standard heat exchanger

Z-2277-2021
Recall number
Z-2277-2021
Initiated
March 22, 2021
Classification
Class II
Status
Terminated
Recalling firm
QURA S.R.L.
Quantity
1088 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product labeled as sterile may not have been adequately sterilized. In addition, these devices were imported to the US distributor, but the devices are not 510(k) cleared in the US.

Code information

Batch Numbers: B000129, C000415, C000416, C000417

Distribution pattern

US Nationwide distribution in the state of South Carolina.