Moderate riskFDA DeviceClass II

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

Medline Convenience Kits containing BD ChloraPrep Clear 1mL applicators from specific lots may have open or incomplete seals on the applicator packaging. This could allow contamination, potentially leading to skin, soft tissue, or systemic infections if used during medical procedures.

From the FDA notice · Read the official notice ↗ · All Medline recalls

What to do

  1. Check if your Convenience Kit contains lots 24IBK346, 24JBK539, 25CBF097, 25HBB232, 25HBB761, 25HBH209, 25HBU907, or 25JBQ176.
  2. Do not use applicators with damaged or open seals.
  3. Contact your healthcare facility or Medline for instructions on replacement or proper disposal.

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators OPEN HEART CDS983348AA CDS983348AB
Sold in
Nationwide
Made for
Adults

This recall covers 13 products — see all of them.

Details

Units affected
222,653 total
Illnesses reported
None reported
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Classification
Class II
Recall number
Z-3068-2026

In the FDA's words

Description
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators OPEN HEART CDS983348AA CDS983348AB Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications. CDS983348AA UDI-DI 10195327385088 Lots 24IBK346 24JBK539; CDS983348AB UDI-DI 10198459136986 Lots 25CBF097 25HBB232 25HBB761 25HBH209 25HBU907 25JBQ176 Distribution: US Nationwide distribution. Affected quantity: 222,653 total
Hazard
Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.

13 products in this recall

Medline convenience kits recalled for ChloraPrep applicator seal defect

Medline is recalling 13 convenience kits that contain BD ChloraPrep Clear 1mL applicators from specific lots. The applicator packaging may have an open or incomplete seal, so the applicator could be contaminated. Contaminated applicators can cause skin or soft tissue infections, or more serious infections, and no injuries have been reported.

The agency lists each product separately. Check every one you might have.

Updates since first reported

  • Oct 6, 2026Hazard description updated

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