Reported Jul 8, 2026 · Ongoing
BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 100 x…
CareFusion 213, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: CareFusion 213, LLC · 1550 Northwestern Dr · El Paso, TX · 79912-8000
Is this the product you have?
- BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 100 x 3 mL applicators/case, NDC 54365-400-33
- calatog 930415NSb) 250 x 3mL applicators/case, bulk catalog number 930415NSB; STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co
- Lot codes and dates
- Lot
a) 3194046Exp. 06/30/20263217036Exp 07/31/20263279434Exp 09/30/202632862683304460Exp 10/31/20263346277Exp 11/30/202640316864039656Exp 01/31/2027404894940604374067207Exp 02/28/2027409277340949784106623Exp 03/31/202741203714129596Exp 04/30/20274144918Exp 05/31/20274193623 4200771Exp 06/30/202742277474250845Exp 08/31/2027508726105093809Exp 03/31/20285121323Exp 04/30/2028. b) 3331331Exp 11/30/20264284935Exp 10/31/20274344682Exp 11/30/20275015852Exp 01/31/20285086227Exp 03/31/2028
- Lot
- Amount recalled
- 7,650 units
This recall covers 10 products
The agency filed one notice per product. You are reading one of them; the other 9 are below.
Where it was sold
- Nationwide
Why it was recalled
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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