Recall Z-2271-2018— CryoLife, Inc.
Class II · Terminated
Class II FDA medical device recall by CryoLife, Inc., initiated 2018-05-14, terminated 2019-03-29. It names one FDA 510(k) clearance: K092021. Product: Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO. Reason: Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxicology reports indicated the presence of morphine in the urine..
- Recalling firm
- CryoLife, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-05-14
- Terminated
- 2019-03-29
- Firm location
- Kennesaw, GA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.