Recall Z-3075-2026— Medline Industries, LP
Class II · Ongoing
Class II FDA medical device recall by Medline Industries, LP, initiated 2026-07-20. FDA's recall record names no specific 510(k) clearance for this event. Product: Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PATIENT ADMIN KIT DYKA1384B DYKA1384C WELCOME KIT DYKS1206D. Reason: 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..
- Recalling firm
- Medline Industries, LP
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-07-20
- Firm location
- Northfield, IL, United States
Product description
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PATIENT ADMIN KIT DYKA1384B DYKA1384C WELCOME KIT DYKS1206D
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.