Recall Z-1219-2019— CryoLife, Inc.
Class II · Terminated
Class II FDA medical device recall by CryoLife, Inc., initiated 2016-11-21, terminated 2019-09-24. It names one FDA 510(k) clearance: K091626. Product: CryoPatch SG Pulmonary Hemi-Artery Patch. Reason: 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..
- Recalling firm
- CryoLife, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-11-21
- Terminated
- 2019-09-24
- Firm location
- Kennesaw, GA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
CryoPatch SG Pulmonary Hemi-Artery Patch
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.