FDA-Device2026-09-09Class IIPACKAGING DEFECT

Medline Convenience Kits with BD ChloraPrep applicators recalled for unsealed packaging

Nationwide distributionMedical devices

What this means

Medline Industries is recalling specific lots of Convenience Kits that contain BD ChloraPrep Clear applicators. The applicator packaging may have an open or incomplete seal, which could allow contamination. If a contaminated applicator is used, it may cause skin, soft tissue, or systemic infection.

  • Check if you have a Medline Convenience Kit with model DYNJ42828B (Basin Pack) or DYNJ42832B (Eye Basin Tray) and a lot number listed in this recall.
  • Do not use applicators from affected lots.
  • Contact Medline Industries or your healthcare facility for instructions on product replacement or disposal.
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 BASIN PACK-LF DYNJ42828B EYE BASIN TRAY-LF DYNJ42832B

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3069-2026

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