Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO
Reported: June 27, 2018 Initiated: May 14, 2018 #Z-2271-2018
Product Description
Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO
Reason for Recall
Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxicology reports indicated the presence of morphine in the urine.
Details
- Recalling Firm
- CryoLife, Inc.
- Units Affected
- 1 unit
- Distribution
- AR, OH
- Location
- Kennesaw, GA
Frequently Asked Questions
What product was recalled? ▼
Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO. Recalled by CryoLife, Inc.. Units affected: 1 unit.
Why was this product recalled? ▼
Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxicology reports indicated the presence of morphine in the urine.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 27, 2018. Severity: Moderate. Recall number: Z-2271-2018.
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