PlainRecalls
FDA Devices Moderate Class II Ongoing

Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: IV START KIT LAB DRAW-SH, REF CDS860014P

Reported: July 30, 2025 Initiated: June 12, 2025 #Z-2154-2025

Product Description

Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: IV START KIT LAB DRAW-SH, REF CDS860014P

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.

Details

Units Affected
184 units
Distribution
Distributed domestically to California, Florida, Pennsylvania, and Texas. No international distribution.
Location
Northfield, IL

Frequently Asked Questions

What product was recalled?
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: IV START KIT LAB DRAW-SH, REF CDS860014P. Recalled by MEDLINE INDUSTRIES, LP - Northfield. Units affected: 184 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 30, 2025. Severity: Moderate. Recall number: Z-2154-2025.