Exact FDA event identifier

Event 86178

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

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Event summary

Timeline bucket: July 30, 2020
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

KIT, PRE OP DRAH - Product Usage: Preoperative kit used to decolonize intranasal S. aureus.

Z-3016-2020

Recall number: Z-3016-2020
Initiated: July 30, 2020
Classification: Class II
Status: Terminated
Recalling firm: Cardinal Health 200, LLC
Quantity: 9,150 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Only providing one nasal swab in our pre-operative kit instead of the 4 required for proper treatment.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Only providing one nasal swab in our pre-operative kit instead of the 4 required for proper treatment.

Code information

Model: ORPDH5994A Lot numbers: 558357, 561502,566549, 571467, 574058. Expiration dates: Varies by kit components.

Distribution pattern

US Nationwide distribution including the state of North Carolina.