CryoLife Pulmonary Hemi-Artery Graft Recalled for Labeling Error
CryoLife, Inc. is recalling one CryoPatch SG Pulmonary Hemi-Artery graft because the conduit and branch lengths were switched on the product labeling.
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 2/5 (Moderate).
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 hazard is a minor labeling error regarding dimensions without reported injuries or illnesses, fitting the Moderate severity criteria.
Plain-English summary
CryoLife, Inc. is recalling one unit of the CryoPatch SG Pulmonary Hemi-Artery graft. The recall is due to a labeling error where the conduit length and branch length were switched on the product packaging.
The affected product is identified by Model Number SGPH00, Serial Number 10978889, Lot Number 144125, and an expiration date of 05/16/2022. The distribution was limited to the state of California. The labeling incorrectly indicates the conduit length is 1.0cm and the branch length is 4.5cm, whereas these dimensions were switched on the label.
Healthcare providers and patients should stop using the affected graft and contact CryoLife, Inc. for further instructions or a replacement.
The recalled product
- Product
- CryoPatch SG Pulmonary Hemi-Artery, 1 graft
- Manufacturer
- CryoLife, Inc.
- Category
- Medical Device — Surgical Graft
- Hazard
- Affected units
- 1
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 (4)
- Model Number SGPH00
- Serial Number 10978889
- Lot Number 144125
- Expiration Date 05/16/2022
Distribution
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