FDA-Device2026-09-09Class IIPACKAGING DEFECT

Medline Convenience Kits with BD ChloraPrep applicators recalled for potential seal failure and infection risk

OTHERNationwide distributionMedical devices

What this means

BD ChloraPrep Clear applicators in certain Medline pre-op convenience kits may have open or incomplete seals on their packaging. If a sealed applicator is compromised, it could become contaminated and cause a skin, soft tissue, or systemic infection when used.

  • Check if you have one of the affected pre-op kits (DYKS2018, DYKS1584A, DYKS1216I, or DYKM1398B).
  • Do not use the ChloraPrep applicators if the package seal appears open, incomplete, or damaged.
  • Contact Medline or your supplier for instructions on replacement or disposal.
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 DELUXE PRE OP KIT DYKS2018 GENERAL PREOP KIT DYKS1584A PRE OP KIT DYKS1216I PRE-OP KIT DYKM1398B

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3074-2026

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