Medical device recalls Moderate risk

MEDLINE INDUSTRIES, LP - Northfield recalls Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: IV START KIT LAB DRAW-SH, REF CD…

Recall date
June 12, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2154-2025
FDA classification
Class II
Brand / firm
MEDLINE INDUSTRIES, LP - Northfield
Sold / distributed
Distributed domestically to California, Florida, Pennsylvania, and Texas. No international distribution.

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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