Stop using now Drug recall · FDA · Published April 20, 2021

BD ChloraPrep Hi-Lite Orange 26mL Applicator Recall: Loose Endcap Risks Glass Shards

CareFusion recalls BD ChloraPrep Hi-Lite Orange 26mL applicators with loose endcaps that may release glass shards. Stop using immediately to avoid injury.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0373-2021Drug CareFusion ›

Stop using this now

Defective Delivery System: An increase in complaints identified endcap being loose or falling off upon activation releasing glass shards containing the solution.

Take action

Contact the company

Recalling firmCareFusion 213, LLC1550 Northwestern Dr · El Paso, TX 79912-8000

✎ GovInfoNow plain-language explainer

CareFusion is recalling BD ChloraPrep Hi-Lite Orange 26 mL applicators due to a loose endcap that can fall off during use, potentially releasing glass shards. This poses a risk of injury from sharp glass fragments. Read more at govinfonow.com/recall/36205-bd-chloraprep-hi-lite-orange-26ml-applicator-recall-loose-endcap.

Source Summary by GovInfoNow · govinfonow.com/recall/36205-bd-chloraprep-hi-lite-orange-26ml-applicator-recall-loose-endcap · Updated October 4, 2026 · FDA enforcement record: FDA #D-0373-2021

Cite this page

“BD ChloraPrep Hi-Lite Orange 26mL Applicator Recall: Loose Endcap Risks Glass Shards.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36205-bd-chloraprep-hi-lite-orange-26ml-applicator-recall-loose-endcap. Based on FDA recall #D-0373-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0373-2021%22&limit=1).

CareFusion 213, LLC voluntarily recalled BD ChloraPrep Hi-Lite Orange 26 mL Applicators on April 20, 2021, according to the FDA. The defective delivery system may release glass shards containing the solution. Owners should contact the company for a refund.

How to tell if you have it

Brand: CareFusion
Product: BD ChloraPrep Hi-Lite Orange 26 mL Applicator (2% w/v chlorhexidine gluconate (CHG) and 70% v/v Isopropyl alcohol)
NDC: 54365-400-38
Lot codes: 0108186, 0327867, 0327868, 0328213, 0338656, 0339071, 0328947, 0328949, 0329475, 0329477, 0330457, 0330955, 0330606, 0333826, 0333852, 0333855, 0334119, 0335787, 0335792, 0335029, 0336506, 0336972, 0336051, 0337245, 0337025, 0338653, 0338542, 0338852, 0339892, 0339457
Expiration dates: 4/30/2023 and 11/30/2023
Quantity: 707,050 eaches

The hazard

An increase in complaints identified the endcap being loose or falling off upon activation, releasing glass shards containing the solution. This defect poses a risk of injury from broken glass.

Context

GovInfoNow's records show CareFusion 213, LLC has 16 other recalls on record since 2011-11-08. Other recent recalls of similar products include BD ChloraPrep Clear 60x1mL (2026-07-09), BD ChloraPrep Clear (2026-06-11), and BD ChloraPrep Clear 1mL Applicator (2026-05-28). Other recent recalls of similar products include Sun Pharmaceutical DOXOrubin Liposome Injection (2026-05-12), Baxter 0.9% Sodium Chloride Injection (2026-08-17), and Mallinckrodt Acthar Gel 5mL Vial (2026-08-06).

How to tell if you have this one

Check for the BD ChloraPrep Hi-Lite Orange 26 mL applicator with lot numbers listed in the recall (e.g., 0108186, 0327867). The product expires by 4/30/2023 or 11/30/2023 depending on the lot.

Brand
CareFusion
Category
Drug

Based on the official FDA remedy

What to do — step by step

Stop Using Immediately
Discontinue use of the recalled applicator to prevent injury from glass shards.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 2.2 years after the firm started it.

Apr 20, 2021Firm started the recall
May 10, 2021FDA classified it Class I
May 19, 2021Published in FDA’s Enforcement Report
Jun 21, 2023FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Which lot numbers are affected?

Lot numbers include 0108186, 0327867, 0327868, 0328213, 0338656, 0339071, 0328947, 0328949, 0329475, 0329477, 0330457, 0330955, 0330606, 0333826, 0333852, 0333855, 0334119, 0335787, 0335792, 0335029, 0336506, 0336972, 0336051, 0337245, 0337025, 0338653, 0338542, 0338852, 0339892, 0339457.

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Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/36205-bd-chloraprep-hi-lite-orange-26ml-applicator-recall-loose-endcap">BD ChloraPrep Hi-Lite Orange 26mL Applicator Recall: Loose Endcap Risks Glass Shards (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0373-2021 (April 20, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0373-2021 to see it in context.
Plain-language summary written by qwen3:4b on October 4, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.