FDA-Device2026-09-09Class IIPACKAGING DEFECT

Medline Convenience Kits with BD ChloraPrep applicators recalled for open packaging seal risk

OTHERNationwide distributionMedical devices

What this means

Medline Convenience Kits containing BD ChloraPrep Clear applicators may have open or incomplete seals on the applicator packaging. Specific lots across four kit models (CDS860014Q, DYKM1000B, CDS860014P, DYNDV2684) are affected. If a compromised applicator is used, it could introduce contamination and lead to skin, soft tissue, or systemic infection.

  • Check if you have one of the affected kits or lot numbers listed in the recall notice.
  • Do not use applicators from affected lots; contact your healthcare facility or supplier for replacement kits.
  • Report any infections or adverse effects related to use of these kits to your healthcare provider or Medline.
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 IV START KIT LAB DRAW-SH CDS860014Q IV START KIT DYKM1000B IV START KIT LAB DRAW-SH CDS860014P ULTRASOUND GUIDED PIV START KI DYNDV2684

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3071-2026

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