FDA-Drug2026-01-07Class IIPROCESSING DEFECT

BD ChloraPrep Triple Swabsticks recalled for sterility assurance issue

OTHERNationwide distribution

Stop using BD ChloraPrep Triple Swabsticks

CareFusion 213, LLC is recalling BD ChloraPrep Triple Swabsticks (a skin antiseptic swab) because the manufacturer cannot confirm the product was properly sterilized. The affected lot (#5086623, expiring 3/31/2028) was distributed nationwide. No injuries have been reported.

  • Check if you have lot #5086623 of BD ChloraPrep Triple Swabsticks
  • Stop using the product immediately
  • Contact your supplier or the manufacturer for instructions on return or replacement
  • Call your healthcare provider if the product was already used and you have concerns
Hazard

Lack of Assurance of Sterlity

Sold states
Nationwide within the United States
Affected count
106,400 units
Manufactured in
1550 Northwestern Dr, N/A, El Paso, TX, United States
Products
BD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG), 2% w/v and Isopropyl alcohol (IPA), 70% v/v), 5.25 mL Applicator, CareFusion 213, LLC, El Paso, TX 79912, NDC 54365-401-29

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0243-2026

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