FDA Medical Device Recalls (openFDA)
CryoLife, Inc.: BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J
- Recall number
- Z-2623-2017
- Recalling firm
- CryoLife, Inc.
- Product
- BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J
- Status
- Terminated
- Initiated
- 2017-05-19
- Posted
- not on file
- Terminated
- 2019-02-08
- Reason
- The courtesy labels in 9 boxes of BioGlue were incorrectly labeled as lot 17MJX007 instead of lot 17MJX002.
- Root cause
- Labeling mix-ups
- Action
- Firm notified customer on approximately 06/02/2017 via letter. Instructions included to inspect inventory on hand, to destroy the incorrect courtesy labels and replace them with the correct labels what were shipped.
- Quantity
- 705 single pack boxes
- Distribution
- Product distributed in Japan.
- Lot, serial or model codes
- Lot Code 17MJX002, Model/Catalog Number BG3510-5-J
- 510(k) numbers
- not on file
- PMA numbers
- ["P010003"]
- Product code
- MUQ
- 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