FDA-Device2026-09-09Class IIPACKAGING DEFECT

Medline Convenience Kits with BD ChloraPrep applicators recalled for potential packaging seal failure

Nationwide distributionMedical devices

What this means

Medline Industries is recalling specific lots of Convenience Kits that contain BD ChloraPrep Clear applicators because some applicators may have open or incomplete seals on their packaging. If a contaminated applicator is used during a medical procedure, it could cause a skin, soft tissue, or systemic infection.

  • Check if you have Medline Convenience Kits (Ortho Aspiration Kit, model DYKM1636A) with lot 26EBI940.
  • Do not use affected applicators.
  • Contact Medline or your healthcare facility to report the product and arrange a replacement.
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
All ages
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 ORTHO ASPIRATION KIT DYKM1636A

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3079-2026

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