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 Industries is recalling specific lots of Convenience Kits that contain BD ChloraPrep Clear 1mL applicators due to a manufacturer recall of those applicators. Some applicators may have open or incomplete seals on their packaging, which could allow contamination. Using a contaminated applicator could lead to skin, soft tissue, or systemic infections.

  • Check if you have affected lots: 25AMD225, 25BMA495, 25GMD834, 25HMJ685, 26AMD781, 26DMI370, 26FMG952, or 26FMJ739.
  • Do not use applicators with damaged or incomplete seals.
  • Contact Medline or your healthcare facility for instructions on returning affected kits or obtaining replacements.
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 BLOOD CULTURE KIT 2 W/CONNECT DYNDH1487A

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3072-2026

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