Z-0105-2022 Class II Terminated
FDA device recall Z-0105-2022 was initiated by Centese Inc. on August 31, 2021 and is designated Class II. Reason for recall: An adhesive joint in the SmartValve component of the device can become compromised resulting in a leak. The recall status is terminated (terminated August 7, 2023). Affected quantity: 310 kits.
Recall Details
- Product Type
- Devices
- Report Date
- October 20, 2021
- Initiation Date
- August 31, 2021
- Termination Date
- August 7, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 310 kits
Product Description
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.
Distribution Pattern
Distribution to a single consignee located in California.
Code Information
Model: FGS-1126 Catalog Number: TGCT120020 Lot Numbers 20100102, 21031703, and 21053102