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Terminated

Thoraguard Chest Tube Kit, 20 Fr

FDA Recall Z-0105-2022 · Posted None

Recalling FirmCentese Inc.
Recall StatusTerminated
Product CodeGBX
Date Initiated2021-08-31
Date Terminated2023-08-07
Product Quantity310 kits

Reason for Recall

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

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.

Root Cause

Under Investigation by firm

Distribution Pattern

Distribution to a single consignee located in California.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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