FDA recall Z-2153-2025

MEDLINE INDUSTRIES, LP - Northfield · Class II · device

Product

Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: LABOR TRIAGE KIT, REF DYKM1564

Reason for recall

Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by BD due to potential to exhibit an open seal on its packaging. This may constitute a breach to sterility, which may in turn lead to the infection related harms for the patient.

Distribution

Distributed domestically to California, Florida, Pennsylvania, and Texas. No international distribution.

Key facts

Status: Ongoing
Initiation date: 2025-06-12
Report date: 2025-07-30
Voluntary/Mandated: Voluntary: Firm initiated
Location: Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2153-2025