PV Bulletin

Convenience Kit Correction: Medline Issues Correction for Convenience Kits Containing BD ChloraPrep Applicators

The FDA has issued a Class II Recall regarding certain BD ChloraPrep Applicators in Convenience Kits by Medline, highlighting potential sterility breaches.

Primary source: What is an Early Alert?

Translated From Korean

PV Bulletin does not take any responsibility for translation errors or omissions, though it has used the best available translation engine.

PV Impact Brief

Urgency: HighConfidence: high

What changed

The issue has been classified as a Class II Recall. The FDA added additional lot numbers to the affected product list and notified the public of potential health risks associated with the use of non-sterile kits.

Why it matters

This corrective action addresses health risks associated with non-sterile components in medical devices, ensuring patient safety and compliance with regulatory standards.

Action needed

Affected healthcare facilities and distributors must immediately check their stock, remove BD ChloraPrep applicators from all kits, apply over-labels indicating the need for component removal, and notify any customers if they have transferred or resold these products.

Relevant for
Regulatory Intelligence LeadMedical Safety Lead
Processes impacted
Signal ManagementInspection Readiness
Owner

Regulatory Intelligence Lead

Review cadence

Review in the next regulatory intelligence cycle.

Evidence and confidence

Confidence: highSource updated: Sep 2, 2026

Full briefing

Practical implication

Affected healthcare facilities and distributors must immediately check their stock, remove BD ChloraPrep applicators from all kits, apply over-labels indicating the need for component removal, and notify any customers if they have transferred or resold these products.

The FDA updated communication on a Class II Recall for Medline Convenience Kits containing BD ChloraPrep Applicators due to concerns that some kits may not be sterile. This includes specific guidance to remove affected components and apply over-labels to inform users of required actions.

What changed: The issue has been classified as a Class II Recall. The FDA added additional lot numbers to the affected product list and notified the public of potential health risks associated with the use of non-sterile kits.

Why it matters: This corrective action addresses health risks associated with non-sterile components in medical devices, ensuring patient safety and compliance with regulatory standards.

Practical implication: Affected healthcare facilities and distributors must immediately check their stock, remove BD ChloraPrep applicators from all kits, apply over-labels indicating the need for component removal, and notify any customers if they have transferred or resold these products.

View original source

  • Source: FDA - MedWatch Safety Alerts RSS
  • Published at source: 2026-09-02T00:00:00.000Z
  • Discovered by monitor: 2026-09-02T21:40:20.836Z

Published from the regulator source ingestion pipeline after PV impact triage.

#Safety Signals#Device Vigilance#Source-ingestion#Regulator-monitor#Usa#Fda.gov#Translated From Korean

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