Cryovalve(R) SG Pulmonary Human Heart Valve recall
Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO
Why was Cryovalve(R) SG Pulmonary Human Heart Valve recalled?
Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxicology reports indicated the presence of morphine in the urine.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial Number 10988203
- Product
- Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO
- Recalling firm
- CryoLife, Inc.
- Quantity
- 1 unit
- Distribution
- AR, OH
- Recall date
- June 27, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)