FDA-Device2026-09-09Class IIPACKAGING DEFECT

Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for contamination risk

OTHERNationwide distributionMedical devices

What this means

Medline Convenience Kits containing BD ChloraPrep Clear applicators are being recalled because some applicator packages may have broken or incomplete seals. If the applicator is contaminated, it could cause skin, soft tissue, or systemic infections when used for blood draws.

  • Check if you have any of the affected Medline Convenience Kits using the lot numbers listed on the FDA recall notice.
  • Do not use applicators from affected lots.
  • Contact your supplier or Medline for instructions on returning or replacing the kits.
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 ADULT BLOOD CULTURE KIT DYNDH1444D BLOOD CULTR KT DIVRSN DEVICE DYNDH1866 BLOOD CULTURE KIT DYNDH1462B DYNDH1622C DYNDH1622D DYNDH1622F DYNDH1715B DYNDH2028 DYNDH2048 BLOOD CULTURE-NB DYNDH2089 BLOOD DRAW KIT DYLAB1081 FLOORS BLOOD DRAW KIT DYLAB1080 PEDS BLOOD CULTURE KIT DYNDH1445C PERIPHERAL BLOOD CULTURE KIT DYNDH2350 WICHITA BLOOD CULTURE COLLECT DYNDH2093

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3073-2026

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