Pulmonary Hemi-Artery SG recallZ-0809-2014 · CryoLife, Inc. · initiated Nov 22, 2013
Class II Terminated All recalls posted in January 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from CryoLife, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-0809-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Nov 22, 2013
- Posted by the FDA
- Jan 23, 2014
- Recalling firm
- CryoLife, Inc.
- Quantity
- One
- Product code
- DXZ
- FDA submissions
- K101866
- Distribution
- US distribution in CA.
Product description
Pulmonary Hemi-Artery SG Used in heart surgery
Code information (models, lots, serial numbers)
Serial No. 10119759, Model SGPH00
Other devices under the same FDA submission
2 devices cleared under K101866 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- CryoPatch® SG Pulmonary Human Cardiac Branch Patch SGP020Artivion, Inc. · Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene2 recalls1 report
- CryoPatch® SG Pulmonary Human Cardiac Hemi-Artery Patch SGPH00Artivion, Inc. · Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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