CLASS II Device recall · Reported 24 Oct 2018 · FDA Enforcement Report
CryoPatch SG Pulmonary Hemi-Artery, 1 graft recalled by CryoLife
CryoLife is recalling CryoPatch SG Pulmonary Hemi-Artery, 1 graft, distributed nationwide in the US. The recall was initiated on 6 Sep 2018 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-0121-2019
- FDA event ID
- 81095
- Recalling firm
- CryoLife, Kennesaw, GA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Sep 2018
- FDA classified
- 17 Oct 2018
- Reported
- 24 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 6 Sep 2018 | Recall initiated by company | |
| 17 Oct 2018 | Classified by FDA | +41 days |
| 24 Oct 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The conduit length and branch length of a SG Pulmonary Hemi-Artery were switched on the product labeling. The graft labeling indicates the conduit length is 1.0cm and the branch length is 4.5cm.
Product as listed by the FDA
CryoPatch SG Pulmonary Hemi-Artery, 1 graft
Where it was distributed
US Nationwide in the state of California.
Questions about this recall
Why was it recalled?
The conduit length and branch length of a SG Pulmonary Hemi-Artery were switched on the product labeling. The graft labeling indicates the conduit length is 1.0cm and the branch length is 4.5cm.
Which lots are affected?
Model Number SGPH00, Serial Number 10978889, Lot Number 144125, Expiration Date 05/16/2022
Where was it sold?
US Nationwide in the state of California.
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.
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