Medications & Supplements/Topical Products

CareFusion 213, LLC: BD ChloraPrep Applicators Recalled Due to Fungal Contamination

Agency Publication Date: August 19, 2020

Summary

Approximately 7,085,600 units of BD ChloraPrep 3 mL Applicators, used for skin preparation before medical procedures, are being recalled because they may contain the fungus Aspergillus Penicilloides. This recall includes clear and tinted versions of the antiseptic applicators sold under the brand names BD ChloraPrep and ChloraPrep One-Step. The contamination was discovered during sterility testing and affects millions of units distributed globally, including Puerto Rico and Guam. If you have these medical supplies, you should check your lot numbers immediately and contact your healthcare provider if the product has already been used.

Risk

The presence of Aspergillus Penicilloides in a product meant to be sterile poses a serious risk of infection, especially for patients with weakened immune systems or those undergoing invasive medical procedures. Exposure to this fungus can lead to severe health complications, including systemic infections or local skin reactions at the site of application.

What You Should Do

Identify your product by checking the packaging for BD ChloraPrep Clear 3 mL (NDC 54365-400-32), ChloraPrep With Tint Hi-Lite Orange (NDC 054365-400-11), or ChloraPrep One-Step Clear (NDC 054365-400-01).
Check the lot numbers on your 3 mL applicator cartons. For the Clear version, look for lots 0065386 (Exp. 2/28/2023) or 0091666 (Exp. 3/31/2023). For the Tinted Hi-Lite Orange version, check for dozens of lots including 7194739, 8127657, 9241932, and 0037279 with various expiration dates through early 2023. For the One-Step Clear version, check for lots including 7240735, 8095620, 9199815, and 0104864.
Stop using any affected applicators immediately and quarantine them to ensure they are not used in clinical settings.
Contact your healthcare provider or pharmacist if you have concerns about a procedure where these applicators may have been used.
Return any unused, recalled products to your pharmacy or the place of purchase for a refund and contact CareFusion 213, LLC (a subsidiary of Becton, Dickinson and Company) for further instructions on disposal or return.
For additional questions or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Healthcare provider consultation and pharmacy refund

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 Clear 3 mL Applicators (2% w/v CHG and 70% v/v IPA) Sterile Solution

Model:

NDC 54365-400-32

Lot Numbers:

0065386 (Exp. 2/28/2023)

0091666 (Exp. 3/31/2023)

Date Ranges: Expiration dates through March 31, 2023

Product: ChloraPrep With Tint (2% w/v CHG and 70% v/v IPA) 3 mL applicators - Hi-Lite Orange

Model:

NDC 054365-400-11

Lot Numbers (51):

7194739 (Exp. 06/25/2020)

7214841 (Exp. 07/17/2020)

7213558 (Exp. 07/16/2020)

7227839 (Exp. 07/30/2020)

7276589 (Exp. 09/20/2020)

7198824 (Exp. 06/29/2020)

7275718 (Exp. 09/19/2020)

7289776 (Exp. 09/30/2020)

7306916 (Exp. 10/12/2020)

8011665 (Exp. 12/14/2020)

8015801 (Exp. 12/18/2020)

8031857 (Exp. 01/31/2021)

8033645 (Exp. 01/31/2021)

8127657 (Exp. 04/30/2021)

8137527 (Exp. 05/31/2021)

8157141 (Exp. 05/31/2021)

8158638 (Exp. 05/31/2021)

8164530 (Exp. 06/30/2021)

8220737 (Exp. 07/31/2021)

8235991 (Exp. 08/31/2021)

8043978 (Exp. 01/31/2021)

8306694 (Exp. 10/31/2021)

8334983 (Exp. 11/30/2021)

9031893 (Exp. 01/31/2022)

9038599 (Exp. 01/31/2022)

9042938 (Exp. 01/31/2022)

9051563 (Exp. 02/28/2022)

9053560 (Exp. 02/28/2022)

9072856 (Exp. 02/28/2022)

9086532 (Exp. 03/31/2022)

9137904 (Exp. 05/31/2022)

9087985 (Exp. 03/31/2022)

9191256 (Exp. 06/30/2022)

9168975 (Exp. 06/30/2022)

9218464 (Exp. 07/31/2022)

9218595 (Exp. 07/31/2022)

9228305 (Exp. 08/31/2022)

9241932 (Exp. 08/31/2022)

9247742 (Exp. 08/31/2022)

9249471 (Exp. 08/31/2022)

9269603 (Exp. 09/30/2022)

9296395 (Exp. 10/31/2022)

9295914 (Exp. 10/31/2022)

9311076 (Exp. 10/31/2022)

9316348 (Exp. 11/30/2022)

9324565 (Exp. 11/30/2022)

9345911 (Exp. 11/30/2022)

9305775 (Exp. 10/31/2022)

0011737 (Exp. 12/31/2022)

0023790 (Exp. 01/31/2023)

Date Ranges: Expiration dates between June 25, 2020 and January 31, 2023

Product: ChlroraPrep One-Step (2% w/v CHG and 70% v/v IPA) 3 mL Applicator - Clear

Model:

NDC 054365-400-01

Lot Numbers (69):

7240735 (Exp. 08/09/2020)

7235540 (Exp. 08/06/2020)

7297579 (Exp. 10/08/2020)

8003727 (Exp. 11/29/2020)

8011688 (Exp. 12/18/2020)

8012808 (Exp. 12/18/2020)

8095620 (Exp. 03/31/2021)

8087784 (Exp. 03/31/2021)

8106737 (Exp. 04/30/2021)

8130509 (Exp. 04/30/2021)

8165721 (Exp. 06/30/2021)

8187644 (Exp. 06/30/2021)

8205560 (Exp. 07/31/2021)

8247508 (Exp. 08/31/2021)

8289654 (Exp. 09/30/2021)

8155991 (Exp. 05/31/2021)

8304783 (Exp. 10/31/2021)

8337646 (Exp. 11/30/2021)

8332585 (Exp. 11/30/2021)

8338794 (Exp. 11/30/2021)

9007921 (Exp. 12/31/2021)

9015917 (Exp. 12/31/2021)

9015920 (Exp. 12/31/2021)

9030934 (Exp. 01/31/2022)

9045819 (Exp. 01/31/2022)

9052554 (Exp. 02/28/2022)

9059817 (Exp. 02/28/2022)

9046572 (Exp. 02/28/2022)

9071761 (Exp. 02/28/2022)

9087982 (Exp. 03/31/2022)

9087980 (Exp. 03/31/2022)

9100768 (Exp. 03/31/2022)

9101529 (Exp. 03/31/2022)

9092575 (Exp. 03/31/2022)

9105675 (Exp. 03/31/2022)

9113528 (Exp. 04/30/2022)

9123753 (Exp. 04/30/2022)

9133928 (Exp. 04/30/2022)

9135816 (Exp. 05/31/2022)

9165856 (Exp. 05/31/2022)

9199815 (Exp. 06/30/2022)

9166196 (Exp. 06/30/2022)

9198900 (Exp. 06/30/2022)

9194257 (Exp. 06/30/2022)

9200420 (Exp. 06/30/2022)

9205441 (Exp. 07/31/2022)

9233323 (Exp. 08/31/2022)

9233645 (Exp. 08/31/2022)

9241929 (Exp. 08/31/2022)

9238871 (Exp. 08/31/2022)

Date Ranges: Expiration dates between August 6, 2020 and March 31, 2023

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85903

Status: Resolved

Manufacturer: CareFusion 213, LLC

Sold By: medical supply distributors; pharmacies; hospitals

Manufactured In: United States

Units Affected: 3 products (12,500 applicators; 2,800,800 applicators; 4,272,300 applicators)

Distributed To: Puerto Rico

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 your product by checking the packaging for BD ChloraPrep Clear 3 mL (NDC 54365-400-32), ChloraPrep With Tint Hi-Lite Orange (NDC 054365-400-11), or ChloraPrep One-Step Clear (NDC 054365-400-01).

Check the lot numbers on your 3 mL applicator cartons. For the Clear version, look for lots 0065386 (Exp. 2/28/2023) or 0091666 (Exp. 3/31/2023). For the Tinted Hi-Lite Orange version, check for dozens of lots including 7194739, 8127657, 9241932, and 0037279 with various expiration dates through early 2023. For the One-Step Clear version, check for lots including 7240735, 8095620, 9199815, and 0104864.

Stop using any affected applicators immediately and quarantine them to ensure they are not used in clinical settings.

Contact your healthcare provider or pharmacist if you have concerns about a procedure where these applicators may have been used.

Return any unused, recalled products to your pharmacy or the place of purchase for a refund and contact CareFusion 213, LLC (a subsidiary of Becton, Dickinson and Company) for further instructions on disposal or return.

For additional questions or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: BD ChloraPrep Clear 3 mL Applicators (2% w/v CHG and 70% v/v IPA) Sterile Solution

Model:

NDC 54365-400-32

Lot Numbers:

0065386 (Exp. 2/28/2023)

0091666 (Exp. 3/31/2023)

Date Ranges: Expiration dates through March 31, 2023

Product: ChloraPrep With Tint (2% w/v CHG and 70% v/v IPA) 3 mL applicators - Hi-Lite Orange

Model:

NDC 054365-400-11

Lot Numbers (51):

7194739 (Exp. 06/25/2020)

7214841 (Exp. 07/17/2020)

7213558 (Exp. 07/16/2020)

7227839 (Exp. 07/30/2020)

7276589 (Exp. 09/20/2020)

7198824 (Exp. 06/29/2020)

7275718 (Exp. 09/19/2020)

7289776 (Exp. 09/30/2020)

7306916 (Exp. 10/12/2020)

8011665 (Exp. 12/14/2020)

8015801 (Exp. 12/18/2020)

8031857 (Exp. 01/31/2021)

8033645 (Exp. 01/31/2021)

8127657 (Exp. 04/30/2021)

8137527 (Exp. 05/31/2021)

8157141 (Exp. 05/31/2021)

8158638 (Exp. 05/31/2021)

8164530 (Exp. 06/30/2021)

8220737 (Exp. 07/31/2021)

8235991 (Exp. 08/31/2021)

8043978 (Exp. 01/31/2021)

8306694 (Exp. 10/31/2021)

8334983 (Exp. 11/30/2021)

9031893 (Exp. 01/31/2022)

9038599 (Exp. 01/31/2022)

9042938 (Exp. 01/31/2022)

9051563 (Exp. 02/28/2022)

9053560 (Exp. 02/28/2022)

9072856 (Exp. 02/28/2022)

9086532 (Exp. 03/31/2022)

9137904 (Exp. 05/31/2022)

9087985 (Exp. 03/31/2022)

9191256 (Exp. 06/30/2022)

9168975 (Exp. 06/30/2022)

9218464 (Exp. 07/31/2022)

9218595 (Exp. 07/31/2022)

9228305 (Exp. 08/31/2022)

9241932 (Exp. 08/31/2022)

9247742 (Exp. 08/31/2022)

9249471 (Exp. 08/31/2022)

9269603 (Exp. 09/30/2022)

9296395 (Exp. 10/31/2022)

9295914 (Exp. 10/31/2022)

9311076 (Exp. 10/31/2022)

9316348 (Exp. 11/30/2022)

9324565 (Exp. 11/30/2022)

9345911 (Exp. 11/30/2022)

9305775 (Exp. 10/31/2022)

0011737 (Exp. 12/31/2022)

0023790 (Exp. 01/31/2023)

Date Ranges: Expiration dates between June 25, 2020 and January 31, 2023

Product: ChlroraPrep One-Step (2% w/v CHG and 70% v/v IPA) 3 mL Applicator - Clear

Model:

NDC 054365-400-01

Lot Numbers (69):

7240735 (Exp. 08/09/2020)

7235540 (Exp. 08/06/2020)

7297579 (Exp. 10/08/2020)

8003727 (Exp. 11/29/2020)

8011688 (Exp. 12/18/2020)

8012808 (Exp. 12/18/2020)

8095620 (Exp. 03/31/2021)

8087784 (Exp. 03/31/2021)

8106737 (Exp. 04/30/2021)

8130509 (Exp. 04/30/2021)

8165721 (Exp. 06/30/2021)

8187644 (Exp. 06/30/2021)

8205560 (Exp. 07/31/2021)

8247508 (Exp. 08/31/2021)

8289654 (Exp. 09/30/2021)

8155991 (Exp. 05/31/2021)

8304783 (Exp. 10/31/2021)

8337646 (Exp. 11/30/2021)

8332585 (Exp. 11/30/2021)

8338794 (Exp. 11/30/2021)

9007921 (Exp. 12/31/2021)

9015917 (Exp. 12/31/2021)

9015920 (Exp. 12/31/2021)

9030934 (Exp. 01/31/2022)

9045819 (Exp. 01/31/2022)

9052554 (Exp. 02/28/2022)

9059817 (Exp. 02/28/2022)

9046572 (Exp. 02/28/2022)

9071761 (Exp. 02/28/2022)

9087982 (Exp. 03/31/2022)

9087980 (Exp. 03/31/2022)

9100768 (Exp. 03/31/2022)

9101529 (Exp. 03/31/2022)

9092575 (Exp. 03/31/2022)

9105675 (Exp. 03/31/2022)

9113528 (Exp. 04/30/2022)

9123753 (Exp. 04/30/2022)

9133928 (Exp. 04/30/2022)

9135816 (Exp. 05/31/2022)

9165856 (Exp. 05/31/2022)

9199815 (Exp. 06/30/2022)

9166196 (Exp. 06/30/2022)

9198900 (Exp. 06/30/2022)

9194257 (Exp. 06/30/2022)

9200420 (Exp. 06/30/2022)

9205441 (Exp. 07/31/2022)

9233323 (Exp. 08/31/2022)

9233645 (Exp. 08/31/2022)

9241929 (Exp. 08/31/2022)

9238871 (Exp. 08/31/2022)

Date Ranges: Expiration dates between August 6, 2020 and March 31, 2023

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85903

Status: Resolved

Manufacturer: CareFusion 213, LLC

Sold By: medical supply distributors; pharmacies; hospitals

Manufactured In: United States

Units Affected: 3 products (12,500 applicators; 2,800,800 applicators; 4,272,300 applicators)

Distributed To: Puerto Rico