CryoPatch SG Pulmonary Hemi-Artery Patch recall
CryoPatch SG Pulmonary Hemi-Artery Patch
Why was CryoPatch SG Pulmonary Hemi-Artery Patch 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.
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 #: SGPHOO Serial #10685466
- Product
- CryoPatch SG Pulmonary Hemi-Artery Patch
- Recalling firm
- CryoLife, Inc.
- Quantity
- 1
- Distribution
- Product was shipped to Texas
- Recall date
- May 1, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)