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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 198
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
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