RegWardenFDA facility compliance records
Recall

Class II — Cardinal Health 200, LLC

Recalling firmCardinal Health 200, LLC
Registered facilityView this company's 35 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonOnly providing one nasal swab in our pre-operative kit instead of the 4 required for proper treatment.
ProductKIT, PRE OP DRAH - Product Usage: Preoperative kit used to decolonize intranasal S. aureus.
Quantity9,150 kits
DistributionUS Nationwide distribution including the state of North Carolina.
Initiated2020-07-30
Classified2020-09-25
Terminated2021-04-28
Recall numberZ-3016-2020
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Cardinal Health 200, LLC (Z-3016-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86178/

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