CryoLife Pulmonary Hemi-Artery Patch Recalled for Donor Infection
CryoLife is recalling a pulmonary hemi-artery patch because the tissue donor tested positive for Enterobacter cloacae.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a Class II medical device with a confirmed positive blood culture for a pathogenic bacterium (Enterobacter cloacae) in the tissue donor, which poses a significant risk of infection to the recipient.
Plain-English summary
CryoLife, Inc. is recalling one unit of the CryoPatch SG Pulmonary Hemi-Artery Patch (Model #: SGPHOO, Serial #10685466). The recall was initiated because the firm received information indicating that the tissue donor's blood culture tested positive for Enterobacter cloacae, rendering the donor ineligible for tissue release.
The product was shipped to Texas. This recall is classified as Class II by the U.S. Food and Drug Administration.
Consumers and healthcare facilities should stop using the affected device and contact CryoLife, Inc. for further instructions or a replacement.
The recalled product
- Product
- CryoPatch SG Pulmonary Hemi-Artery Patch
- Manufacturer
- CryoLife, Inc.
- Category
- Medical Device — Tissue Graft
- 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)
- Model #: SGPHOO Serial #10685466
Distribution
Distributed in 1 state:
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