Recall Z-0121-2019— CryoLife, Inc.
Class II · Terminated
Class II FDA medical device recall by CryoLife, Inc., initiated 2018-09-06, terminated 2020-03-03. It names one FDA 510(k) clearance: K091626. Product: CryoPatch SG Pulmonary Hemi-Artery, 1 graft. Reason: 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..
- Recalling firm
- CryoLife, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-09-06
- Terminated
- 2020-03-03
- 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, 1 graft
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.