CryoPatch SG Pulmonary Hemi-Artery Patch
Reported: May 1, 2019 Initiated: November 21, 2016 #Z-1219-2019
Product Description
CryoPatch SG Pulmonary Hemi-Artery Patch
Reason for Recall
The device is recalled due to donor ineligibility of released human tissue. The firm received information that the tissue donor's blood culture tested positive for Enterobacter cloacae.
Details
- Recalling Firm
- CryoLife, Inc.
- Units Affected
- 1
- Distribution
- Product was shipped to Texas
- Location
- Kennesaw, GA
Frequently Asked Questions
What product was recalled? ▼
CryoPatch SG Pulmonary Hemi-Artery Patch. Recalled by CryoLife, Inc.. Units affected: 1.
Why was this product recalled? ▼
The device is recalled due to donor ineligibility of released human tissue. The firm received information that the tissue donor's blood culture tested positive for Enterobacter cloacae.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 1, 2019. Severity: Moderate. Recall number: Z-1219-2019.
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