FDA Medical Device Recalls (openFDA)
CryoLife, Inc.: Cryopatch SG Pulmonary Human Cardiac Branch, Catalog Number SGP020
- Recall number
- Z-2272-2018
- Recalling firm
- CryoLife, Inc.
- Product
- Cryopatch SG Pulmonary Human Cardiac Branch, Catalog Number SGP020
- Status
- Terminated
- Initiated
- 2018-05-14
- Posted
- not on file
- Terminated
- 2019-03-29
- Reason
- Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxicology reports indicated the presence of morphine in the urine.
- Root cause
- Under Investigation by firm
- Action
- The firm notified the consignees by letter on 05/14/2018.
- Quantity
- 1 unit
- Distribution
- AR, OH
- Lot, serial or model codes
- Serial Number 10988328
- 510(k) numbers
- ["K101866"]
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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