CryoLife Recalls Two On-X Aortic Heart Valves for Mislabeled Serial Numbers
CryoLife, Inc. is recalling two On-X Aortic Heart Valves because they were mislabeled with incorrect serial numbers. The devices were distributed in Georgia and Germany.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a documentation and labeling issue (incorrect serial number) with no reported injuries or illnesses, fitting the criteria for a Low severity recall.
Plain-English summary
CryoLife, Inc. is recalling two units of the On-X Aortic Heart Valve with Anatomic Sewing Ring. The recall is due to a labeling error where the devices were marked with incorrect serial numbers. The affected product is a bileaflet mechanical heart valve indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position.
The recall involves two specific devices with Model/Catalog Number ONXANE - 23, Lot number 6827216, and an expiration date of 11/19/2024. These devices were distributed worldwide, specifically in the United States (Georgia) and Germany.
The source text does not report any illnesses or injuries associated with this recall. Consumers and healthcare providers who have these specific devices should contact CryoLife, Inc. for further instructions on how to proceed.
The recalled product
- Product
- On-X Aortic Heart Valve with Anatomic Sewing Ring Product Usage: The On-X Prosthetic Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position. It is a bileaflet mechanical heart valve, which…
- Manufacturer
- CryoLife, Inc.
- Category
- Medical Device — Heart Valve
- Hazard
- Affected units
- 2
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)
- Model/Catalog Number ONXANE - 23
- Lot number 6827216
- Expiration Date 11/19/2024
Distribution
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