CryoLife Pulmonary Hemi-Artery SG Recalled Due to Donor Testing Concerns
CryoLife, Inc. is recalling one Pulmonary Hemi-Artery SG device used in heart surgery because donor serological testing may have been compromised by hemodilution.
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: The recall involves a high-risk medical device where the integrity of donor screening is compromised, representing a risk of harm where injury has not yet been reported, consistent with the High severity criteria.
Plain-English summary
CryoLife, Inc. is recalling one unit of the Pulmonary Hemi-Artery SG, a medical device used in heart surgery. The recall is limited to the device with Serial No. 10119759 and Model SGPH00, which was distributed in California.
The recall was initiated because serological testing for the donor was performed using a blood sample that may have been hemodiluted. This hemodilution may have occurred due to the administration of normal saline to the donor prior to death, potentially affecting the accuracy of the donor screening results.
Healthcare facilities and patients who may have received this specific device should contact CryoLife, Inc. for further instructions on how to proceed. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Pulmonary Hemi-Artery SG Used in heart surgery
- Manufacturer
- CryoLife, Inc.
- Category
- Medical Device — Surgical Grafts
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 (2)
- Serial No. 10119759
- Model SGPH00
Distribution
Distributed in 1 state:
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