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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Topical Products

BD ChloraPrep Clear Applicators Recalled for Potential Sterility Risk

Agency Publication Date: May 20, 2025
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Summary

CareFusion 213, LLC has recalled 385,200 applicators of BD ChloraPrep Clear (chlorhexidine gluconate and isopropyl alcohol), which is used to prepare a patient's skin before surgery. The recall was issued because some applicators may have an open seal on their individual pouch packaging. This defect means the solution inside is no longer guaranteed to be sterile, which could lead to infections if used during medical procedures. The affected 1 mL applicators were distributed nationwide in the U.S.

Risk

A broken seal on the packaging compromises the sterility of the applicator. If a non-sterile product is used to prepare skin for surgery, it may introduce bacteria or other contaminants into the surgical site, potentially causing serious infections.

What You Should Do

  1. This recall involves BD ChloraPrep Clear (2% chlorhexidine gluconate and 70% isopropyl alcohol) Patient Preoperative Skin Preparation, sold in 1 mL applicators with Catalog Number 930480 and NDC 54365-400-31.
  2. Identify affected products by checking for lot numbers 3354127 or 3350974, both of which have an expiration date of 12/31/2026.
  3. Stop using the recalled product immediately and remove it from your clinical inventory.
  4. Contact the manufacturer, CareFusion 213, LLC, or your product distributor to arrange for the return of all unused applicators from the affected lots.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 with any additional questions or concerns.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation (1 mL)
Variants: Sterile Solution, 1 mL Applicator, 60 Applicators per inner carton
Model:
930480
Lot Numbers:
3354127 (Exp 12/31/2026)
3350974 (Exp 12/31/2026)
NDC:
54365-400-31

Applicator is sterile if package is intact; Flammable; External Use Only.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96879
Status: Active
Manufacturer: CareFusion 213, LLC
Sold By: Medical supply distributors; Hospitals; Surgical centers
Manufactured In: United States
Units Affected: 385,200 applicators
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.