Data Foundry

Medical device recalls 2021

Thoraguard Chest Tube Kit — Class II medical device recall Z-0105-2022

Terminated recall by Centese Inc., reported 2021-10-20, distributed in CA. An adhesive joint in the SmartValve component of the device can become compromised resulting in a leak.

Recall numberZ-0105-2022
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmCentese Inc., Omaha, NE, United States
Recall initiated2021-08-31
Classified2021-10-13
Reported by FDA2021-10-20
Terminated2023-08-07
DistributedCA
Quantity310 kits
Reason classespackaging
Lot numbers20100102, 21031703, 21053102
Model numbersFGS-1126, TGCT120020

Product

Thoraguard Chest Tube Kit, 20 Fr

Reason for recall

An adhesive joint in the SmartValve component of the device can become compromised resulting in a leak.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0105-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.