Z-0105-2022Class II

Thoraguard Chest Tube Kit, 20 Fr

Name: Z-0105-2022 Thoraguard Chest Tube Kit, 20 Fr
Creator: Centese Inc.
Published: 2021-08-31
License: https://open.fda.gov/license/

Centese Inc. / initiated 2021-08-31 / Terminated

FDA source

Centese Inc. began a recall of Thoraguard Chest Tube Kit, 20 Fr on 2021-08-31. FDA classified it as Class II and gives the reason as "An adhesive joint in the SmartValve component of the device can become compromised resulting in a leak". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0105-2022
Classification: Class II
Status: Terminated
Initiated: 2021-08-31
Posted: 2021-10-13
Terminated: 2023-08-07
Recalling firm: Centese Inc.
Product: Thoraguard Chest Tube Kit, 20 Fr
Product code: GBX Catheter, Irrigation
Reason for recall: An adhesive joint in the SmartValve component of the device can become compromised resulting in a leak.
FDA 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 in commerce: 310 kits
Distribution: Distribution to a single consignee located in California.
Product codes and lots: Model: FGS-1126 Catalog Number: TGCT120020 Lot Numbers 20100102, 21031703, and 21053102

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0105-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0105-2022	Class II	Terminated	Voluntary: Firm initiated	2021-10-20	2021-10-13

Product code GBX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)