Cryolife Inc CryoValve Pulmonary Valve SG Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CryoValve Pulmonary Valve SG
Brand
Cryolife Inc
Lot Codes / Batch Numbers
Device Donor number: 64212, Serial Number: 7887101, Model Number: SGPV10
Products Sold
Device Donor number: 64212, Serial Number: 7887101, Model Number: SGPV10
Cryolife Inc is recalling CryoValve Pulmonary Valve SG due to The Amphotericin B Intermediate (G10030), one of the components of the antimicrobial solution, had reached expiration at the time it was utilized to m. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The Amphotericin B Intermediate (G10030), one of the components of the antimicrobial solution, had reached expiration at the time it was utilized to manufacture the Combo Antibiotic Stock Solution (G10070).
Recommended Action
Per FDA guidance
Consignees were notified by letter on 06/17/2004 and 06/18/2004.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, OH, OR, PA
Page updated: Jan 10, 2026