ChlroraPrep One-Step (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL Applicator - Clear, CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC 054365-400-01
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot #: 7240735, Exp. Date 08/09/2020; 7235540, Exp. Date. 08/06/2020; 7297579, Exp. Date 10/08/2020; 8003727, Exp. Date 11/29/2020; 8011688, 8012808, Exp.. Date 12/18/2020; 8095620, 8087784, 8095620, Exp. Date 03/31/2021; 8106737, 8130509, Exp. Date 04/30/2021; 8165721, 8187644, Exp. Date 06/30/2021; 8205560, Exp. Date 07/31/2021; 8247508, Exp. Date 08/31/2021; 8289654, Exp. Date 09/30/2021; 8155991, Exp. Date 05/31/2021; 8304783, Exp. Date 10/31/2021; 8337646, 8332585, 8338794, Exp. Date 11/30/2021; 9007921, 9015917, 9015920, Exp. date 12/31/2021; 9030934, 9045819, Exp. Date 01/31/2022; 9052554, 9059817, 9046572, 9071761, Exp. Date 02/28/2022; 9087982, 9087980, 9100768, 9101529, 9092575, 9105675, Exp. Date 03/31/2022; 9113528, 9123753, 9133928, Exp. Date 04/30/2022; 9135816, 9165856, Exp. Date 05/31/2022; 9199815, 9166196, 9198900, 9199815, 9194257, 9200420, Exp. Date 06/30/2022; 9205441, Exp. Date 07/31/2022; 9233323, 9233645, 9241929, 9238871, 9253785, Exp. Date 08/31/2022; 9261886, 9278673, 9266348, 9289666, Exp. Date 09/30/2022; 9293445, 9291336, 9297772, 9311057, 9305777, Exp. Date 10/31/2022; 9326162, 9344775, 9345956, Exp. Date 11/30/2022; 9352330, 0008777, 0016325, Exp. Date 12/31/2022; 0021072, 0030959, Exp. Date 01/31/2023, 0104864, Exp. Date 03/31/2023.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- CareFusion 213, LLC
- Reason for Recall:
- Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
ChlroraPrep One-Step (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL Applicator - Clear, CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC 054365-400-01
Product Codes/Lot Numbers:
Lot #: 7240735, Exp. Date 08/09/2020; 7235540, Exp. Date. 08/06/2020; 7297579, Exp. Date 10/08/2020; 8003727, Exp. Date 11/29/2020; 8011688, 8012808, Exp.. Date 12/18/2020; 8095620, 8087784, 8095620, Exp. Date 03/31/2021; 8106737, 8130509, Exp. Date 04/30/2021; 8165721, 8187644, Exp. Date 06/30/2021; 8205560, Exp. Date 07/31/2021; 8247508, Exp. Date 08/31/2021; 8289654, Exp. Date 09/30/2021; 8155991, Exp. Date 05/31/2021; 8304783, Exp. Date 10/31/2021; 8337646, 8332585, 8338794, Exp. Date 11/30/2021; 9007921, 9015917, 9015920, Exp. date 12/31/2021; 9030934, 9045819, Exp. Date 01/31/2022; 9052554, 9059817, 9046572, 9071761, Exp. Date 02/28/2022; 9087982, 9087980, 9100768, 9101529, 9092575, 9105675, Exp. Date 03/31/2022; 9113528, 9123753, 9133928, Exp. Date 04/30/2022; 9135816, 9165856, Exp. Date 05/31/2022; 9199815, 9166196, 9198900, 9199815, 9194257, 9200420, Exp. Date 06/30/2022; 9205441, Exp. Date 07/31/2022; 9233323, 9233645, 9241929, 9238871, 9253785, Exp. Date 08/31/2022; 9261886, 9278673, 9266348, 9289666, Exp. Date 09/30/2022; 9293445, 9291336, 9297772, 9311057, 9305777, Exp. Date 10/31/2022; 9326162, 9344775, 9345956, Exp. Date 11/30/2022; 9352330, 0008777, 0016325, Exp. Date 12/31/2022; 0021072, 0030959, Exp. Date 01/31/2023, 0104864, Exp. Date 03/31/2023.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-1511-2020
Related Recalls
Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
Stability data does not support expiry: Shelf-life of the impacted lots of BD ChloraPrep" Clear 1 mL Applicator cannot be substantiated beyond 12-months although labeled with 36-month expiry. Stability studies indicate that the impacted lots, if stored at 30¿C/75% relative humidity continuously beyond 12 months, may exhibit growth of Aspergillus penicillioides.