The Recall Desk
HighFDA (Devices)·Z-0751-2023·Announced 2022-12-28

FDA Class II recall: Medical Action cardiac catheter introduction kit

Medical Action Industries' Port a Cath Kit (cardiac catheter introduction kit) has been subject to an FDA Class II recall affecting 198 cases distributed in Virginia. The specific reason for recall was not provided by the FDA.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II FDA recall of an invasive cardiac catheter device, which constitutes a risk-of-harm product used in cardiac procedures. Although no reported illnesses or injuries are noted in the source, the device classification and inherent clinical risk warrant a High severity rating.

Plain-English summary

A cardiac catheter introduction kit, the Medical Action INDUSTRIES INC. Port a Cath Kit (REF 58647D), has been recalled by the U.S. Food and Drug Administration as a Class II recall. The recall involves 198 cases distributed in Virginia. The specific reason for the recall was not stated in the FDA notification.

The recall was initiated on November 4, 2022, on a voluntary basis by Medical Action Industries, Inc. Affected lot numbers are 297223 and 297418, identified by UDI/DI 10809160156681.

The recall status was terminated on March 18, 2026.

The recalled product

Product
Medical Action INDUSTRIES INC. Port a Cath Kit REF 58647D, cardiac catheter introduction kit
Manufacturer
Medical Action Industries, Inc. 306
Category
Medical Device — Cardiac Catheter

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • UDI/DI 10809160156681
  • Lot Numbers: 297223
  • 297418

Distribution

Distributed nationwide across the United States.

Related recalls

Same category