FDA-Device2026-09-09Class IIPACKAGING DEFECT

Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for defective packaging seals

OTHERNationwide distributionMedical devices

What this means

Medline Industries recalled specific lots of Convenience Kits that contain BD ChloraPrep Clear skin antiseptic applicators. Some applicators may have open or incomplete seals on their packaging, which could allow contamination. Using a compromised applicator could lead to skin, soft tissue, or systemic infection.

  • Check your Medline Convenience Kit for the affected lot numbers (starting with 24J, 24K, 25A–25L, or 26A–26F).
  • Do not use applicators from affected lots.
  • Contact Medline or your supplier for instructions on how to return or replace the kits.
  • If you have used an applicator from an affected lot and notice signs of infection (redness, warmth, swelling, or fever), contact your healthcare provider.
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 LABOR CDS CDS981762B VAG DELIVERY ADMISSION BAG DYKA1054F

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3076-2026

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