CLASS II Device recall · Reported 1 May 2019 · FDA Enforcement Report
CryoPatch SG Pulmonary Hemi-Artery Patch recalled by CryoLife
CryoLife is recalling CryoPatch SG Pulmonary Hemi-Artery Patch, distributed in Texas. The recall was initiated on 21 Nov 2016 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-1219-2019
- FDA event ID
- 82380
- Recalling firm
- CryoLife, Kennesaw, GA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Nov 2016
- FDA classified
- 25 Apr 2019
- Reported
- 1 May 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 21 Nov 2016 | Recall initiated by company | |
| 25 Apr 2019 | Classified by FDA | +885 days |
| 1 May 2019 | 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
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.
Product as listed by the FDA
CryoPatch SG Pulmonary Hemi-Artery Patch
Where it was distributed
Product was shipped to Texas
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Model #: SGPHOO Serial #10685466
Where was it sold?
Product was shipped to Texas
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 | On-X Aortic Heart Valve with Anatomic Sewing Ring recalled by CryoLife | CryoLife | Labeling Errors | Nationwide |
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