Has CareFusion 213, LLC had other FDA enforcement actions?

Yes. Argus HQ has recorded 17 total FDA actions tied to CareFusion 213, LLC: 1 warning letter, 16 recalls, 0 approval records, and 0 Form 483 inspection citations.

What kind of FDA record is this?

This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2026-07-08; Argus observed and indexed it on 2026-07-14.

Where can I verify this record directly with FDA?

The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

.hq

fda_recall · drug_recall · high

CareFusion 213, LLC — Class II recall: BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v…

Name: FDA Recall Record — CareFusion 213, LLC
Creator: Argus HQ
Published: 2026-07-08
License: https://argushq.ai/methodology

Event date: 2026-07-08 00:00:00Z
Observed: 2026-07-14 04:20:18Z
Source ID: D-0647-2026
Payload hash: 9bdd441f44809082247d4129…

Summary

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel Status: Ongoing.

Entities

CareFusion 213, LLC

View source record ↗

Frequently asked questions

Has CareFusion 213, LLC had other FDA enforcement actions?: Yes. Argus HQ has recorded 17 total FDA actions tied to CareFusion 213, LLC: 1 warning letter, 16 recalls, 0 approval records, and 0 Form 483 inspection citations.
What kind of FDA record is this?: This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2026-07-08; Argus observed and indexed it on 2026-07-14.
Where can I verify this record directly with FDA?: The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). CareFusion 213, LLC — Class II recall: BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v…. Digital Empire LLC. Retrieved from https://argushq.ai/events/fda-recall-carefusion-213-llc-d-0647-2026

MLA

"CareFusion 213, LLC — Class II recall: BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v…." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/events/fda-recall-carefusion-213-llc-d-0647-2026.

Chicago

Argus HQ Research. "CareFusion 213, LLC — Class II recall: BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v…." Digital Empire LLC. Accessed July 14, 2026. https://argushq.ai/events/fda-recall-carefusion-213-llc-d-0647-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_carefusion_213_llc_d_0647_2026_2026,
  title = {CareFusion 213, LLC — Class II recall: BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/events/fda-recall-carefusion-213-llc-d-0647-2026},
  note = {Accessed: July 14, 2026}
}

Informational only. Not legal, financial, or medical advice.