FDA-Device2026-09-09Class IIPACKAGING DEFECT

Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for potential contamination

Nationwide distributionMedical devices

What this means

Medline Convenience Kits containing BD ChloraPrep Clear 1mL applicators may have packaging with open or incomplete seals. This can allow contamination of the applicator, which is used to prepare skin before surgery. If a contaminated applicator is used, it could cause skin or soft tissue infection.

  • Check if you have affected lots: 25BBB005, 25GBY063, 25KBI862, 25LBT688, or 26CBG211.
  • Do not use applicators with damaged or compromised packaging.
  • Contact Medline or your healthcare provider for replacement or further instructions.
The agency's original wording
Hazard

Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the applicator. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.

Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
222,653 total
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators C-SECTION PREP DYNJ32702B

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3077-2026

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