FDA Medical Device Recalls (openFDA)
CryoLife, Inc.: CryoPatch SG Pulmonary Hemi-Artery, 1 graft
- Recall number
- Z-0121-2019
- Recalling firm
- CryoLife, Inc.
- Product
- CryoPatch SG Pulmonary Hemi-Artery, 1 graft
- Status
- Terminated
- Initiated
- 2018-09-06
- Posted
- not on file
- Terminated
- 2020-03-03
- 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.
- Root cause
- Labeling mix-ups
- Action
- A formal recall notice was not sent to the customer involved. The customer complaint was followed up on and the affected graft returned prior to the initiation of the recall for investigation.
- Quantity
- 1 graft
- Distribution
- US Nationwide in the state of California.
- Lot, serial or model codes
- Model Number SGPH00, Serial Number 10978889, Lot Number 144125, Expiration Date 05/16/2022
- 510(k) numbers
- ["K091626"]
- PMA numbers
- not on file
- Product code
- DXZ
- Firm FEI
- 3001451326
- Firm city
- Kennesaw
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28