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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87343

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

Open FDA event record

Event summary

Timeline bucket
February 11, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Cardinal Health 200, LLC

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

JUDKINS PACK

Z-1256-2021
Recall number
Z-1256-2021
Initiated
February 11, 2021
Classification
Class II
Status
Terminated
Recalling firm
Cardinal Health 200, LLC
Quantity
298 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Component Part Number: 19537LBL (LBL, SHEET OF 39, ASSORTED, STDSZ, MULTI W/BLK INK, WATERPROOF) is being reported as intermittently mixed with an incorrect medication label sheet throughout the specific Presource¿ kit SANHDJTVCF Judkins Pack lot # 525067.

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

Component Part Number: 19537LBL (LBL, SHEET OF 39, ASSORTED, STDSZ, MULTI W/BLK INK, WATERPROOF) is being reported as intermittently mixed with an incorrect medication label sheet throughout the specific Presource¿ kit SANHDJTVCF Judkins Pack lot # 525067.

Code information

Model SANHDJTVCF, lot 525067.

Distribution pattern

US state of VA.