FDAFDA recall Z-3068-2026 · Sep 9, 2026
Medline Industries, LP: Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators OPEN HEART CDS98 recall
Recall found
Product
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators OPEN HEART CDS983348AA CDS983348AB
Reason for recall
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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- CDS983348AA UDI-DI 10195327385088 Lots 24IBK346 24JBK539; CDS983348AB UDI-DI 10198459136986 Lots 25CBF097 25HBB232 25HBB761 25HBH209 25HBU907 25JBQ176
- Quantity
- 222,653 total
- Distribution
- US Nationwide distribution.
- Recalling firm
- Medline Industries, LP, Northfield, IL
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-07-20
Source: openFDA enforcement record Z-3068-2026 · search recall number Z-3068-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.