Reported May 1, 2019 · Terminated
CryoPatch SG Pulmonary Hemi-Artery Patch
CryoLife, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: CryoLife, Inc. · 1655 Roberts Blvd Nw · Kennesaw, GA · 30144-3632
Is this the product you have?
- CryoPatch SG Pulmonary Hemi-Artery Patch
- Lot codes and dates
- Model #: SGPHOO Serial #10685466
- Amount recalled
- 1
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new CryoLife, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.