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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88741

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

Open FDA event record

Event summary

Timeline bucket
December 08, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Smiths Medical ASD 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

smiths medical portex Loss of Resistance Device, REF 100/398/000

Z-0152-2022
Recall number
Z-0152-2022
Initiated
December 08, 2020
Classification
Class II
Status
Terminated
Recalling firm
Smiths Medical ASD Inc.
Quantity
3420 devices

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
labeling was missing

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

The labeling was missing information on sterilization and prohibition of reuse.

Code information

Lot Numbers: 3980977, 3986734, 3994302, 3994303 and 4001003

Distribution pattern

Canada. Belgium, Great Britain, Ireland, Czech Republic, Spain, France, Switzerland, Israel, Germany, Sweden, Italy, New Zealand, Australia, South Africa, Netherlands, Slovenia, United Arab Emirates