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CareFusion 213: Multiple Subsidiary Of Beckton Solutions
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DRUG RECALLMODERATE

CareFusion 213: Multiple Subsidiary Of Beckton Solutions

BD recalls ChloraPrep & PurPrep applicators due to lack of sterility assurance, posing infection risk.

What to do

Do not use these products. Quarantine any affected applicators and contact BD for return and replacement instructions.

Recalled
Listed
Updated
Recall No.
D-0643-2026
Agency
FDA
Firm
CareFusion 213, LLC
Recall ID
99217
Status
ONGOING

Why it was recalled

BD is recalling multiple antiseptic skin preparation products, including ChloraPrep Hi-Lite Orange, ChloraPrep Clear, ChloraPrep Scrub Teal, ChloraPrep FREPP, and PurPrep applicators, because they were distributed without assurance of sterility. These unsterilized applicators, intended for further processing, were shipped outside the intended distribution channel, posing a risk of infection.

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.

Timeline

  1. Publicly announced
  2. Listed on Recall Canary
  3. Firm initiated recall
  4. Summary updated

Other Sterility Failure recalls

Other recent recalls from CareFusion 213, LLC

All recalls from CareFusion 213, LLC

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Editorial summary by Recall Canary · summary updated 2026-09-03 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification