Has CareFusion 213, LLC received FDA warning letters?

Yes, 1 warning letter on file. See the full history below for each one.

Has CareFusion 213, LLC had product recalls?

Yes, 6 recalls on file. See the full history below for each one.

Is this FDA enforcement data for CareFusion 213, LLC official?

Every record links directly to its primary FDA.gov source. Argus HQ aggregates and structures public FDA data; the verbatim FDA record is always the source of truth.

How many FDA actions has CareFusion 213, LLC had?

Argus HQ has recorded 7 FDA events for CareFusion 213, LLC: 1 warning letters, 6 recalls, 0 approvals, and 0 Form 483 inspection observations. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

CareFusion 213, LLC — FDA Enforcement History

FDA action counts

Total FDA actions	7
Warning letters	1
Recalls	6
Approval records	0
Form 483 inspection citations	0
Most recent action	July 1, 2026

The short version: Argus HQ has recorded 7 FDA events for CareFusion 213, LLC: 1 warning letters, 6 recalls, 0 approvals, and 0 inspection 483 observations. These events span from 2026-04-30 to 2026-07-01. The most severe rating Argus HQ has assigned across this history is "critical". Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed.

Enforcement history

On 2026-04-30, Argus HQ recorded a FDA Warning Letter for CareFusion 213, LLC, rated "critical" severity in Argus HQ's classification: CareFusion 213, LLC — CGMP/Finished Pharmaceuticals/Adulterated (2026-04-30) An FDA Warning Letter is FDA's formal notice that inspectors found significant violations requiring prompt correction. On 2026-05-13, Argus HQ recorded a FDA recall for CareFusion 213, LLC, rated "high" severity in Argus HQ's classification: CareFusion 213, LLC — Class II recall: BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alc… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-13, Argus HQ recorded a FDA recall for CareFusion 213, LLC, rated "high" severity in Argus HQ's classification: CareFusion 213, LLC — Class II recall: BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alc… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-07-01, Argus HQ recorded a FDA recall for CareFusion 213, LLC, rated "high" severity in Argus HQ's classification: CareFusion 213, LLC — Class II recall: BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-07-01, Argus HQ recorded a FDA recall for CareFusion 213, LLC, rated "high" severity in Argus HQ's classification: CareFusion 213, LLC — Class II recall: BD ChloraPrep FREPP Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v iso… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-07-01, Argus HQ recorded a FDA recall for CareFusion 213, LLC, rated "critical" severity in Argus HQ's classification: CareFusion 213, LLC — Class I recall: BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-07-01, Argus HQ recorded a FDA recall for CareFusion 213, LLC, rated "critical" severity in Argus HQ's classification: CareFusion 213, LLC — Class I recall: BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isop… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. In total, CareFusion 213, LLC has 7 FDA events on file with Argus HQ across the sources Argus HQ currently tracks (FDA Warning Letters, recalls, drug/biologic approvals, and Form 483 inspection observations).

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. CareFusion 213, LLC has both FDA warning letters and recalls on file, which may suggest quality-system issues that surfaced in more than one FDA process. CareFusion 213, LLC has 6 separate FDA recalls on file, more than a single isolated recall event. A pattern across multiple FDA touchpoints does not by itself establish that any specific product currently poses a risk; it reflects only the frequency of FDA engagement with this company as recorded in Argus HQ's database. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed.

Frequently asked questions

Has CareFusion 213, LLC received FDA warning letters?: Yes, 1 warning letter on file. See the full history below for each one.
Has CareFusion 213, LLC had product recalls?: Yes, 6 recalls on file. See the full history below for each one.
Is this FDA enforcement data for CareFusion 213, LLC official?: Every record links directly to its primary FDA.gov source. Argus HQ aggregates and structures public FDA data; the verbatim FDA record is always the source of truth.
How many FDA actions has CareFusion 213, LLC had?: Argus HQ has recorded 7 FDA events for CareFusion 213, LLC: 1 warning letters, 6 recalls, 0 approvals, and 0 Form 483 inspection observations. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

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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 — FDA Enforcement History. Digital Empire LLC. Retrieved from https://argushq.ai/company/carefusion-213-llc

MLA

"CareFusion 213, LLC — FDA Enforcement History." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/company/carefusion-213-llc.

Chicago

Argus HQ Research. "CareFusion 213, LLC — FDA Enforcement History." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/company/carefusion-213-llc.

BibTeX

@misc{argushq_argushq_ai_company_carefusion_213_llc_2026,
  title = {CareFusion 213, LLC — FDA Enforcement History},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/company/carefusion-213-llc},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov (aggregated across Warning Letters, Recalls, Approvals, Form 483s) ↗