Notice names this product. CareFusion 213’s ChloraPrep FREPP is named in FDA Class II recall D-0646-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: 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 Identifying details: Lot: 3279063, Exp. 9/30/2026, 3319524, 3324094, 3343541, Exp. 11/30/2026, 3357638, 4010202,Exp. 12/31/2026, 4206771, Exp. 7/31/2027, 4267824, 4270191, 4282285, Exp.9/30/2027, 4338352, Exp. 11/30/2027, 5053657, Exp. 2/29/2028, 5121340, Exp. 4/30/2028.. Units affected: 10,500 units. Status: Ongoing.
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
ChloraPrep FREPP, Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 500 x 1.5 mL applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-30, Catalog number 930599NSB
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of th…
Company / brand: CareFusion 213
Affected product: ChloraPrep FREPP
Official ID D-0646-2026 · Official record ↗
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Compiled from connected official public-domain government data. Sources last checked September 7, 2026 at 6:00 AM UTC.