CryoLife On-X Prosthetic Heart Valve Recall for Incorrect Labeling
CryoLife, Inc. is recalling 52 On-X Prosthetic Heart Valves because the sewing ring type was mislabeled as Standard instead of Anatomic.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a labeling error without reporting any illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
CryoLife, Inc. is recalling 52 units of the On-X Prosthetic Heart Valve. The recall is due to an incorrect product label where the type of Sewing Ring was mislabeled as a Standard Sewing Ring instead of an Anatomic Sewing Ring.
The affected valves are indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic and mitral positions. The recall covers units distributed worldwide, including nationwide in the United States in the states of AL, CA, FL, IA, IN, LA, MA, MN, MO, MS, NC, OR, PA, and TN, as well as in Finland, the United Kingdom, and Israel.
Specific serial numbers are listed in the official recall notice. Healthcare providers and patients should verify the serial numbers of their devices against the list provided by the FDA. If a device is affected, it should be removed from use and returned to the manufacturer or a designated representative.
The recalled product
- Product
- On-X Prosthetic Heart Valve Product Usage: Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic and mitral positions
- Manufacturer
- CryoLife, Inc.
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 52
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 (20)
- Serial #'s: 4622210
- 4587605
- 4741470
- 4750714
- 4622025
- 4737722
- 4737726
- 4632012
- 4237725
- 4616112
- 4520208
- 4520709
- 4632013
- 4771217
- 4771005
- 4781414
- 4782107
- 4782132
- 4765118
- 4750707
Distribution
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