PV Bulletin

AVID Medical Correction for Convenience Kits Containing Medline Namic Star Off Handle Manifolds

AVID Medical is correcting specific convenience kits amid a serious recall related to safety concerns.

Primary source: What is an Early Alert?

PV Impact Brief

Urgency: HighConfidence: high

What changed

Affected convenience kits must be corrected by removing the Medline Namic Off Handle Manifolds, and warning labels must be added to prevent their usage until corrected.

Why it matters

Failure to correct these kits poses a high risk of serious injury or death to patients. The FDA classifies this recall as the most serious type, underscoring the urgent need for compliance.

Action needed

All impacted products must be identified, segregated, and quarantined. Users are required to add appropriate warning labels and must exercise extreme caution if using the Manifolds is unavoidable.

Relevant for
Regulatory Intelligence LeadMedical Safety Lead
Processes impacted
Signal ManagementCountry Compliance
Owner

Regulatory Intelligence Lead

Review cadence

Review in the next regulatory intelligence cycle.

Evidence and confidence

Confidence: highSource updated: Aug 27, 2026

Full briefing

Practical implication

All impacted products must be identified, segregated, and quarantined. Users are required to add appropriate warning labels and must exercise extreme caution if using the Manifolds is unavoidable.

AVID Medical has issued a correction for convenience kits containing Manifolds implicated in a recall due to risks of serious injury or death if used without necessary corrections. This action involves clearly labeling affected products and implementing specific guidance for users.

What changed: Affected convenience kits must be corrected by removing the Medline Namic Off Handle Manifolds, and warning labels must be added to prevent their usage until corrected.

Why it matters: Failure to correct these kits poses a high risk of serious injury or death to patients. The FDA classifies this recall as the most serious type, underscoring the urgent need for compliance.

Practical implication: All impacted products must be identified, segregated, and quarantined. Users are required to add appropriate warning labels and must exercise extreme caution if using the Manifolds is unavoidable.

View original source

  • Source: FDA - Medical Device Safety
  • Published at source: 2026-08-27T14:54:25.000Z
  • Discovered by monitor: 2026-08-27T22:09:01.741Z

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

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