Z-0809-2014Class II

Pulmonary Hemi-Artery SG Used in heart surgery

Name: Z-0809-2014 Pulmonary Hemi-Artery SG Used in heart surgery
Creator: CryoLife, Inc.
Published: 2013-11-22
License: https://open.fda.gov/license/

Artivion, Inc. / initiated 2013-11-22 / Terminated

FDA source

CryoLife, Inc. began a recall of Pulmonary Hemi-Artery SG Used in heart surgery on 2013-11-22. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0809-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-22
Posted: 2014-01-23
Terminated: 2014-02-20
Recalling firm: Artivion, Inc.
Product: Pulmonary Hemi-Artery SG Used in heart surgery
Product code: DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Reason for recall: 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.
FDA root cause: Other
Action: CryoLife sent an Urgent Human Tissue Recall letter dated November 22, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contact CryoLife to arrange for the return of the affected product. If the affected product had been implanted or discarded, customers should provide information regarding the status of the affected product on the attached self-addressed postcard. Customers with questions were instructedto contact the Field Assurance Department at 800-438-8285. For questions regarding this recall call 770-419-3355.
Quantity in commerce: One
Distribution: US distribution in CA.
Product codes and lots: Serial No. 10119759, Model SGPH00

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0809-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0809-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-29	2014-01-23

Product code DXZ

K101866Class IICryopatch Sg Pulmonary Human Cardiac PatchCryolife, Inc. / cleared 2010-07-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)