CryoPatch SG Pulmonary Hemi-Artery recall: Labeling Error
CryoPatch SG Pulmonary Hemi-Artery, 1 graft
Why was CryoPatch SG Pulmonary Hemi-Artery 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Number SGPH00, Serial Number 10978889, Lot Number 144125, Expiration Date 05/16/2022
- Product
- CryoPatch SG Pulmonary Hemi-Artery, 1 graft
- Recalling firm
- CryoLife, Inc.
- Quantity
- 1 graft
- Distribution
- US Nationwide in the state of California.
- Recall date
- October 24, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)