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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89164

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

Open FDA event record

Event summary

Timeline bucket
December 01, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
MEDLINE INDUSTRIES, LP - Northfield

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

Michels Transport Medium, 20ML Prefilled Cont

Z-0656-2022
Recall number
Z-0656-2022
Initiated
December 01, 2021
Classification
Class II
Status
Terminated
Quantity
2,816 units (22 cases, 128 per case)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product stored incorrectly in temperature controlled setting instead of refrigeration.

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

Product stored incorrectly in temperature controlled setting instead of refrigeration.

Code information

Model Number: AZSES3270, all lots with expiration date range of 08/28/2021 through 09/03/2023

Distribution pattern

US Nationwide distribution in the states of Colorado, Florida, New York, North Carolina, and Texas.