Z-1219-2019Class II

CryoPatch SG Pulmonary Hemi-Artery Patch

Name: Z-1219-2019 CryoPatch SG Pulmonary Hemi-Artery Patch
Creator: CryoLife, Inc.
Published: 2016-11-21
License: https://open.fda.gov/license/

Artivion, Inc. / initiated 2016-11-21 / Terminated

FDA source

CryoLife, Inc. began a recall of CryoPatch SG Pulmonary Hemi-Artery Patch on 2016-11-21. FDA classified it as Class II and gives the reason as "The device is recalled due to donor ineligibility of released human tissue. The firm received information that the tissue donor's blood culture tested positive for Enterobacter cloacae". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1219-2019
Classification: Class II
Status: Terminated
Initiated: 2016-11-21
Posted: 2019-04-25
Terminated: 2019-09-24
Recalling firm: Artivion, Inc.
Product: CryoPatch SG Pulmonary Hemi-Artery Patch
Product code: DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Reason for recall: The device is recalled due to donor ineligibility of released human tissue. The firm received information that the tissue donor's blood culture tested positive for Enterobacter cloacae.
FDA root cause: Release of Material/Component prior to receiving test results
Action: The firm sent the physician a letter on 11/21/2016.
Quantity in commerce: 1
Distribution: Product was shipped to Texas
Product codes and lots: Model #: SGPHOO Serial #10685466

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1219-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1219-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-01	2019-04-25

Product code DXZ

K091626Class IICryopatch Sg Pulmonary Hemi-Artery; Trunk; BranchCryolife, Inc. / cleared 2009-08-07

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)