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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87145

6 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
January 07, 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

6 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 6

Covidien ChemoPlus Chemo Spill Kit, Nonsterile, SKU DP5108K

Z-1078-2021
Recall number
Z-1078-2021
Initiated
January 07, 2021
Classification
Class II
Status
Terminated
Recalling firm
Cardinal Health 200, LLC
Quantity
137,346 kits

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign material

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns.

Code information

Lots: 915025X 915026X 915027X 915028X

Distribution pattern

Global Distribution. US Nationwide.

device · product 2 of 6

CHEMOBLOC Preparation and Administration Kit, Extra Large Blue Gown, Medium and Large Gloves, Nonsterile, SKU DP5106K

Z-1079-2021
Recall number
Z-1079-2021
Initiated
January 07, 2021
Classification
Class II
Status
Terminated
Recalling firm
Cardinal Health 200, LLC
Quantity
137,346 kits

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign material

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns.

Code information

Lot: 911609X

Distribution pattern

Global Distribution. US Nationwide.

device · product 3 of 6

CHEMOPLUS DRUG SPILL KIT HOS, SKU CT4004

Z-1080-2021
Recall number
Z-1080-2021
Initiated
January 07, 2021
Classification
Class II
Status
Terminated
Recalling firm
Cardinal Health 200, LLC
Quantity
137,346 kits

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign material

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns.

Code information

Lots: 915016X 915018X

Distribution pattern

Global Distribution. US Nationwide.

device · product 4 of 6

ChemoPlus Drug Spill Kit-INSTI, SKU DP5016K

Z-1081-2021
Recall number
Z-1081-2021
Initiated
January 07, 2021
Classification
Class II
Status
Terminated
Recalling firm
Cardinal Health 200, LLC
Quantity
137,346 kits

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign material

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns.

Code information

Lots: 915019X 915020X 915021X 915022X 924422X 925174X

Distribution pattern

Global Distribution. US Nationwide.

device · product 5 of 6

Kendall Spill Kit, 6 Per Case, NonsterileI, BB6016K

Z-1082-2021
Recall number
Z-1082-2021
Initiated
January 07, 2021
Classification
Class II
Status
Terminated
Recalling firm
Cardinal Health 200, LLC
Quantity
137,346 kits

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign material

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns.

Code information

Lots: 916197X 916881X 919683X 920354X 924620X 928728X 931205X

Distribution pattern

Global Distribution. US Nationwide.

device · product 6 of 6

ChemoPlus" Chemo Prep & Admin Kit, CT4025

Z-1083-2021
Recall number
Z-1083-2021
Initiated
January 07, 2021
Classification
Class II
Status
Terminated
Recalling firm
Cardinal Health 200, LLC
Quantity
137,346 kits

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign material

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns.

Code information

Lot: 923184X

Distribution pattern

Global Distribution. US Nationwide.