CLASS II Device recall · Reported 29 Jan 2014 · FDA Enforcement Report
Pulmonary Hemi-Artery SG Used in heart surgery recalled by CryoLife
CryoLife is recalling Pulmonary Hemi-Artery SG Used in heart surgery, distributed in California. The recall was initiated on 22 Nov 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0809-2014
- FDA event ID
- 67182
- Recalling firm
- CryoLife, Kennesaw, GA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Nov 2013
- FDA classified
- 23 Jan 2014
- Reported
- 29 Jan 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 22 Nov 2013 | Recall initiated by company | |
| 23 Jan 2014 | Classified by FDA | +62 days |
| 29 Jan 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Pulmonary Hemi-Artery SG Used in heart surgery
Where it was distributed
US distribution in CA.
Questions about this recall
Why was it 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.
Which lots are affected?
Serial No. 10119759, Model SGPH00
Where was it sold?
US distribution in CA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from CryoLife
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | BioGlue Surgical Adhesive recalled by CryoLife | CryoLife | Hidden Drug Ingredients | GA |
| Device | CLASS II | CryoPatch SG Pulmonary Human Cardiac Patch recalled by CryoLife | CryoLife | Device Malfunction | Nationwide |
| Device | CLASS II | CryoValve SG Pulmonary Human Heart Valve recalled by CryoLife | CryoLife | Device Malfunction | Nationwide |
| Device | CLASS II | CryoPatch SG Pulmonary Hemi-Artery Patch recalled by CryoLife | CryoLife | Other | TX |
| Device | CLASS II | On-X Aortic Heart Valve with Anatomic Sewing Ring recalled by CryoLife | CryoLife | Labeling Errors | Nationwide |
Other Other Medical Devices recalls
All 13,929| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Rapicide PA Part A High-Level Disinfectant recalled by Steris | Steris | Other | Nationwide |
| Device | CLASS II | NeuroStar Advanced Therapy System recalled by Neuronetics | Neuronetics | Other | Nationwide |
| Device | CLASS II | TS Misc. Instruments Tray, Triathlon recalled by Howmedica Osteonics | Howmedica Osteonics | Sterility | NJ |
| Device | CLASS II | BD Phoenix Panel Nmic recalled by Becton Dickinson | Becton Dickinson | Device Malfunction | Nationwide |
| Device | CLASS II | BD Phoenix Panel Nmic recalled by Becton Dickinson | Becton Dickinson | Device Malfunction | Nationwide |