FDA Recall D-1511-2020

CareFusion 213, LLC · El Paso, TX

Class I — life-threatening Terminated 827 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

Product

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

Lot / code: 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.

Quantity: 4,272,300 applicators

Reason for recall

Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides

Recall record

Recall number: D-1511-2020
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Puerto Rico, Guam, United Arab Emirates, Bahrain, Brazil, Democratic Republic of the Congo, Chile, Colombia, United Kingdom of Great Britain and Northern Ireland, Hong Kong, Israel, Kuwait, Oman, Qatar, Saudi Arabia, Singapore,
Recall initiated: 2020-06-23
Classified by FDA Center: 2020-08-19
FDA published: 2020-08-26
Terminated: 2022-09-28
Recalling firm: CareFusion 213, LLC
Firm location: El Paso, TX

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