FDA-Device2026-09-09Class IIPACKAGING DEFECT

Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for potential seal defect

OTHERNationwide distributionMedical devices

What this means

Medline is recalling Convenience Kits containing BD ChloraPrep Clear 1mL applicators because some units may have an open or incomplete seal on the applicator packaging. This defect could allow contamination, potentially leading to skin, soft tissue, or systemic infection if the applicator is used.

  • Check if you have affected lots: CDS983348AA (lots 24IBK346, 24JBK539) or CDS983348AB (lots 25CBF097, 25HBB232, 25HBB761, 25HBH209, 25HBU907, 25JBQ176).
  • Do not use applicators with visibly damaged, open, or incomplete seals.
  • Contact Medline or your healthcare facility for instructions on replacement or proper disposal.
  • Report any infections or injuries to Medline and 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 OPEN HEART CDS983348AA CDS983348AB

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3068-2026

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