PV Bulletin

Epidural Kit Correction: Medical Action Industries Issues Correction for Epidural Kits Containing Spectra Medical Devices Lidocaine Ampules

Medical Action Industries is correcting epidural kits containing recalled Huons Co. sodium chloride ampules, leading to a Class I Recall by the FDA.

Primary source: What is an Early Alert?

PV Impact Brief

Urgency: HighConfidence: high

What changed

The FDA has classified the issue as a Class I Recall, marking it as the most serious type of recall due to risks of serious injury or death.

Why it matters

This classification requires immediate attention from healthcare providers and manufacturers to prevent potential harm associated with the use of these products.

Action needed

Healthcare providers should quarantine all impacted epidural kits and remove any sodium chloride ampules affected by this recall, implementing corrective actions per FDA guidance.

Relevant for
Regulatory Intelligence LeadPV Quality 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 10, 2026

Full briefing

Practical implication

Healthcare providers should quarantine all impacted epidural kits and remove any sodium chloride ampules affected by this recall, implementing corrective actions per FDA guidance.

The FDA has classified the correction of epidural kits containing Spectra Medical Devices Lidocaine Ampules as a Class I Recall due to potential risks of serious injury or death associated with the affected sodium chloride ampules. Medical Action Industries has advised customers to quarantine these kits until they can be corrected.

What changed: The FDA has classified the issue as a Class I Recall, marking it as the most serious type of recall due to risks of serious injury or death.

Why it matters: This classification requires immediate attention from healthcare providers and manufacturers to prevent potential harm associated with the use of these products.

Practical implication: Healthcare providers should quarantine all impacted epidural kits and remove any sodium chloride ampules affected by this recall, implementing corrective actions per FDA guidance.

View original source

  • Source: FDA - MedWatch Safety Alerts RSS
  • Published at source: 2026-09-10T00:00:00.000Z
  • Discovered by monitor: 2026-09-10T21:31:33.991Z

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

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