Exact FDA event identifier

Event 85903

3 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: June 23, 2020
Product types: Drug
Classifications: Class I
Statuses: Terminated
Recalling firm wording: CareFusion 213, LLC

Dossier provenance

Source snapshots represented here

openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

3 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 3

BD ChloraPrep Clear 3 mL Applicators (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) Sterile Solution, 25 Applicators in carton, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC 54365-400-32

D-1509-2020

Recall number: D-1509-2020
Initiated: June 23, 2020
Classification: Class I
Status: Terminated
Recalling firm: CareFusion 213, LLC
Quantity: 12,500 applicators

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: 0065386 Exp. 2/28/2023; 0091666 Exp. 3/31/2023

Distribution pattern

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,

drug · product 2 of 3

ChloraPrep With Tint (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL applicators - Hi-Lite Orange 25 applicators in carton, CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC 054365-400-11

D-1510-2020

Recall number: D-1510-2020
Initiated: June 23, 2020
Classification: Class I
Status: Terminated
Recalling firm: CareFusion 213, LLC
Quantity: 2,800,800 applicators

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: 7194739, Exp. 06/25/2020; 7214841, Exp. Date 07/17/2020; 7213558, Exp. Date 07/16/2020; 7227839, Exp. Date 07/30/2020; 7276589, Exp. Date 09/20/2020; 7198824, Exp. Date 06/29/2020; 7275718, Exp. Date 09/19/2020; 7289776, Exp. Date 09/30/2020; 7306916, Exp. Date 10/12/2020; 8011665, Exp. Date 12/14/2020; 8015801, Exp. Date 12/18/2020; 8031857, Exp. Date 01/31/2021; 8033645, Exp. Date 01/31/2021; 8127657, Exp. Date 04/30/2021; 8137527, 8157141, 8158638, Exp. Date 05/31/2021; 8164530, Exp. Date 06/30/2021; 8220737, Exp. Date 07/31/2021; 8235991, Exp. Date 08/31/2021; 8043978, Exp. Date 01/31/2021; 8306694, Exp. Date 10/31/2021; 8334983, Exp. Date 11/30/2021; 9031893, 9038599, 9042938, Exp. Date 01/31/2022; 9051563, 9053560, 9072856, Exp. Date 02/28/2022; 9086532, Exp. Date 03/31/2022; 9137904, Exp. Date 05/31/2022; 9087985, Exp. Date 03/31/2022; 9191256, 9168975, Exp. Date 06/30/2022; 9218464, 9218595, Exp. Date 07/31/2022; 9228305, 9241932, 9247742, 9249471, Exp. Date 08/31/2022; 9269603, Exp. Date 09/30/2022; 9296395, 9295914, 9311076, Exp. Date 10/31/2022; 9316348, 9324565, 9345911, Exp. Date 11/30/2022; 9305775, Exp. Date 10/31/2022; 0011737, Exp. Date 12/31/2022; 0023790, 0037279, Exp. Date 01/31/2023.

Distribution pattern

drug · product 3 of 3

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

D-1511-2020

Recall number: D-1511-2020
Initiated: June 23, 2020
Classification: Class I
Status: Terminated
Recalling firm: CareFusion 213, LLC
Quantity: 4,272,300 applicators

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

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.