Pulmonary Hemi-Artery SG Used in heart surgery
Reported: January 29, 2014 Initiated: November 22, 2013 #Z-0809-2014
Product Description
Pulmonary Hemi-Artery SG Used in heart surgery
Reason for Recall
Serological testing for the donor was performed with a blood sample that may have been hemodiluted due to the administration of normal saline to the donor prior to death.
Details
- Recalling Firm
- CryoLife, Inc.
- Units Affected
- One
- Distribution
- US distribution in CA.
- Location
- Kennesaw, GA
Frequently Asked Questions
What product was recalled? ▼
Pulmonary Hemi-Artery SG Used in heart surgery. Recalled by CryoLife, Inc.. Units affected: One.
Why was this product recalled? ▼
Serological testing for the donor was performed with a blood sample that may have been hemodiluted due to the administration of normal saline to the donor prior to death.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 29, 2014. Severity: Moderate. Recall number: Z-0809-2014.
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