CryoLife Pulmonary Cardiac Branch Recalled Due to Morphine Presence
CryoLife, Inc. is recalling one unit of Cryopatch SG Pulmonary Human Cardiac Branch because final autopsy and toxicology reports indicated the presence of morphine in the donor's urine.
What this means for you
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 a hazardous substance (morphine) was detected in the donor, representing a risk of harm even though specific injuries or illnesses have not been reported in the source text.
Plain-English summary
CryoLife, Inc. is recalling one unit of the Cryopatch SG Pulmonary Human Cardiac Branch, Catalog Number SGP020, Serial Number 10988328. The device was distributed to facilities in Arkansas and Ohio.
The recall was initiated because final autopsy and toxicology reports indicated the presence of morphine in the donor's urine. Although the device met FDA and AATB eligibility criteria at the time of distribution, the subsequent toxicology findings necessitated the recall.
Healthcare facilities that received this specific unit should contact CryoLife, Inc. for instructions on how to return or dispose of the product.
The recalled product
- Product
- Cryopatch SG Pulmonary Human Cardiac Branch, Catalog Number SGP020
- Manufacturer
- CryoLife, Inc.
- Category
- Medical Device — Cardiac Tissue
- 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 (1)
- Serial Number 10988328
Distribution
Part of a larger recall action
This product is one of 2 recalled by CryoLife, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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