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CareFusion 213: Multiple Chlorhexidine Gluconate Products
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DRUG RECALLCRITICAL

CareFusion 213: Multiple Chlorhexidine Gluconate Products

CareFusion recalls BD ChloraPrep Clear and FREPP Clear applicators over sterility concerns from lidding wrinkles.

What to do

Stop using the recalled applicators immediately. Check the product NDC (54365-400-31) and lot numbers on the package. Contact CareFusion 213, LLC for instructions on returning the product and obtaining a replacement or refund.

Posted
Updated
Recall No.
D-0622-2026
Agency
Firm
CareFusion 213, LLC
Recall ID
99114
Status
ONGOING

Why it was recalled

CareFusion 213, LLC is recalling BD ChloraPrep Clear and BD ChloraPrep FREPP Clear antiseptic applicators (2% chlorhexidine gluconate and 70% isopropyl alcohol, 1 mL) due to wrinkles in the paper lidding that may compromise the sterile seal, posing a risk of infection. The recall includes four product variants: BD ChloraPrep Clear 1 mL Applicator (60-count), BD ChloraPrep FREPP Clear 1 mL Applicator (60-count), BD ChloraPrep Clear 1 mL Applicator (single), and BD ChloraPrep FREPP Clear 1 mL Applicator (single).

Is mine affected?

Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.

ProductLot codeBest-byNDCCatalog (Ref) Number
BD ChloraPrep™ Clear - 1 mL Applicators403218301/31/202754365-400-31930480
BD ChloraPrep™ FREPP™ Clear 1.5 mL Applicators407300503/31/202754365-400-30930299

Where it was sold

Distributed nationwide.

Other recent recalls from CareFusion 213, LLC

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Editorial summary by Recall Canary · last updated 2026-07-28 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification