Pulmonary Hemi-Artery SG Used in heart surgery recall
Pulmonary Hemi-Artery SG Used in heart surgery
Why was Pulmonary Hemi-Artery SG Used in heart surgery 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.
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 No. 10119759, Model SGPH00
- Product
- Pulmonary Hemi-Artery SG Used in heart surgery
- Recalling firm
- CryoLife, Inc.
- Quantity
- One
- Distribution
- US distribution in CA.
- Recall date
- January 29, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)