Centese Inc. Recall 88616
Description: Thoraguard Chest Tube Kit, 20 Fr
Centese Inc. Recall 88616 Information
Status | Terminated |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-0105-2022 |
Event ID | 88616 |
Event Description | Thoraguard Chest Tube Kit, 20 Fr |
Product Type | Devices |
Distribution | Distribution to a single consignee located in California. |
Quantity | 310 kits |
Recall Reason | An adhesive joint in the SmartValve component of the device can become compromised resulting in a leak. |
Device Classification | 20211020 |
Device Code Info | Model: FGS-1126 Catalog Number: TGCT120020 Lot Numbers 20100102, 21031703, and 21053102 |
Center Classification Date | 20211013 |
Recall Initiation Date | 20210831 |
Recalling Firm | Centese Inc. |
Initial Notification | |
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