FDA Medical Device Recalls (openFDA)
Centese Inc.: Thoraguard Chest Tube Kit, 20 Fr
- Recall number
- Z-0105-2022
- Recalling firm
- Centese Inc.
- Product
- Thoraguard Chest Tube Kit, 20 Fr
- Status
- Terminated
- Initiated
- 2021-08-31
- Posted
- not on file
- Terminated
- 2023-08-07
- Reason
- An adhesive joint in the SmartValve component of the device can become compromised resulting in a leak.
- Root cause
- Under Investigation by firm
- Action
- The impacted consignee was notified via email of the recall on 08/31/2021. The customer has been instructed to immediately cease product use and return all impacted product to the recalling firm.
- Quantity
- 310 kits
- Distribution
- Distribution to a single consignee located in California.
- Lot, serial or model codes
- Model: FGS-1126 Catalog Number: TGCT120020 Lot Numbers 20100102, 21031703, and 21053102
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GBX
- Firm FEI
- 3017435705
- Firm city
- Omaha
- Firm state
- NE
- 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