Medications & Supplements/Topical Products

CareFusion 213, LLC: BD ChloraPrep Applicators Recalled Due to Risk of Glass Shards

Agency Publication Date: May 10, 2021

Summary

CareFusion 213, LLC is recalling 707,050 units of BD ChloraPrep Hi-Lite Orange 26 mL Applicators because the endcap can loosen or fall off when the device is activated. This defect causes the internal glass ampoule to break and release glass shards along with the sterile solution. These products were distributed nationwide across the United States for use in medical settings.

Risk

When the applicator is activated, a loose endcap may allow glass fragments to be released directly onto the patient or healthcare provider, potentially causing lacerations or contaminating the sterile field. There has been an increase in consumer complaints regarding this specific delivery system defect.

What You Should Do

Identify if you have the BD ChloraPrep Hi-Lite Orange 26 mL Applicator (NDC 54365-400-38) by checking the product label and packaging.
Check your supply for Lot number 0108186 with an expiration date of 4/30/2023.
Check your supply for the following Lot numbers, all with an expiration date of 11/30/2023: 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, and 0339457.
Immediately stop using any applicators from the affected lots and set them aside to prevent accidental use.
Contact your healthcare provider or pharmacist for guidance regarding alternative products and return any unused, affected applicators to the place of purchase for a refund.
Contact the manufacturer, CareFusion 213, LLC (a subsidiary of Becton, Dickinson and Co), for further instructions on returning the defective product.
For additional questions or to report a safety issue, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

Full Refund

Return for refund and consultation.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: BD ChloraPrep Hi-Lite Orange 26 mL Applicator (2% w/v chlorhexidine gluconate and 70% v/v Isopropyl alcohol)

Model:

NDC 54365-400-38

Lot Numbers:

0108186 (Exp. 4/30/2023)

0327867 (Exp. 11/30/2023)

0327868 (Exp. 11/30/2023)

0328213 (Exp. 11/30/2023)

0338656 (Exp. 11/30/2023)

0339071 (Exp. 11/30/2023)

0328947 (Exp. 11/30/2023)

0328949 (Exp. 11/30/2023)

0329475 (Exp. 11/30/2023)

0329477 (Exp. 11/30/2023)

0330457 (Exp. 11/30/2023)

0330955 (Exp. 11/30/2023)

0330606 (Exp. 11/30/2023)

0333826 (Exp. 11/30/2023)

0333852 (Exp. 11/30/2023)

0333855 (Exp. 11/30/2023)

0334119 (Exp. 11/30/2023)

0335787 (Exp. 11/30/2023)

0335792 (Exp. 11/30/2023)

0335029 (Exp. 11/30/2023)

0336506 (Exp. 11/30/2023)

0336972 (Exp. 11/30/2023)

0336051 (Exp. 11/30/2023)

0337245 (Exp. 11/30/2023)

0337025 (Exp. 11/30/2023)

0338653 (Exp. 11/30/2023)

0338542 (Exp. 11/30/2023)

0338852 (Exp. 11/30/2023)

0339892 (Exp. 11/30/2023)

0339457 (Exp. 11/30/2023)

Date Ranges: April 30, 2023, November 30, 2023

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87715

Status: Resolved

Manufacturer: CareFusion 213, LLC

Sold By: Hospitals; Medical clinics; Healthcare distributors

Manufactured In: United States

Units Affected: 707,050 eaches

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 · FDA Press Release · 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.

Summary

Risk

What You Should Do

Identify if you have the BD ChloraPrep Hi-Lite Orange 26 mL Applicator (NDC 54365-400-38) by checking the product label and packaging.

Check your supply for Lot number 0108186 with an expiration date of 4/30/2023.

Check your supply for the following Lot numbers, all with an expiration date of 11/30/2023: 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, and 0339457.

Immediately stop using any applicators from the affected lots and set them aside to prevent accidental use.

Contact your healthcare provider or pharmacist for guidance regarding alternative products and return any unused, affected applicators to the place of purchase for a refund.

Contact the manufacturer, CareFusion 213, LLC (a subsidiary of Becton, Dickinson and Co), for further instructions on returning the defective product.

For additional questions or to report a safety issue, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Affected Products

Product: BD ChloraPrep Hi-Lite Orange 26 mL Applicator (2% w/v chlorhexidine gluconate and 70% v/v Isopropyl alcohol)

Model:

NDC 54365-400-38

Lot Numbers:

0108186 (Exp. 4/30/2023)

0327867 (Exp. 11/30/2023)

0327868 (Exp. 11/30/2023)

0328213 (Exp. 11/30/2023)

0338656 (Exp. 11/30/2023)

0339071 (Exp. 11/30/2023)

0328947 (Exp. 11/30/2023)

0328949 (Exp. 11/30/2023)

0329475 (Exp. 11/30/2023)

0329477 (Exp. 11/30/2023)

0330457 (Exp. 11/30/2023)

0330955 (Exp. 11/30/2023)

0330606 (Exp. 11/30/2023)

0333826 (Exp. 11/30/2023)

0333852 (Exp. 11/30/2023)

0333855 (Exp. 11/30/2023)

0334119 (Exp. 11/30/2023)

0335787 (Exp. 11/30/2023)

0335792 (Exp. 11/30/2023)

0335029 (Exp. 11/30/2023)

0336506 (Exp. 11/30/2023)

0336972 (Exp. 11/30/2023)

0336051 (Exp. 11/30/2023)

0337245 (Exp. 11/30/2023)

0337025 (Exp. 11/30/2023)

0338653 (Exp. 11/30/2023)

0338542 (Exp. 11/30/2023)

0338852 (Exp. 11/30/2023)

0339892 (Exp. 11/30/2023)

0339457 (Exp. 11/30/2023)

Date Ranges: April 30, 2023, November 30, 2023