FDAFDA · Food and drugs·Recall number Z-0809-2014
Pulmonary Hemi-Artery SG Used in heart surgery
Published January 29, 2014 · Recall initiated: November 22, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- CryoLife, Inc.
- Distributor
- US distribution in CA.
- Lot
- Serial No. 10119759, Model SGPH00
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.