FDA-Device2026-09-09Class IIPACKAGING DEFECT

Medline Cataract Preop Kits recalled for potentially contaminated ChloraPrep applicators

Nationwide distributionMedical devices

What this means

Medline Convenience Kits containing BD ChloraPrep Clear applicators may have open or incomplete seals on the applicator packaging. If used, a potentially contaminated applicator could cause a skin, soft tissue, or systemic infection.

  • Check if you have Medline Cataract Preop Kit DYKS1583A, Lot 24KBP388.
  • Do not use the kit if you have the affected lot.
  • Contact Medline or your healthcare provider for instructions on safe disposal or replacement.
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 CATARACT PREOP KIT DYKS1583A

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3078-2026

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