FDA-Device2026-09-09Class IIPACKAGING DEFECT

Medline Convenience Kits with BD ChloraPrep applicators recalled for potential contamination

Nationwide distributionMedical devices

What this means

Medline Convenience Kits containing certain lots of BD ChloraPrep Clear applicators may have packaging seals that are open or incomplete. These applicators could be contaminated and may cause skin infections or more serious infections if used.

  • Check if you have Medline Convenience Kits with model numbers DYKA1384B, DYKA1384C, or DYKS1206D
  • Do not use applicators from the affected lots listed in this recall
  • Contact Medline or your healthcare provider if you have already used an applicator from an affected lot
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 PATIENT ADMIN KIT DYKA1384B DYKA1384C WELCOME KIT DYKS1206D

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3075-2026

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