Recall Z-0105-2022
Centese Inc. · initiated August 31, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Thoraguard Chest Tube Kit, 20 Fr
Codes / lots: Model: FGS-1126 Catalog Number: TGCT120020 Lot Numbers 20100102, 21031703, and 21053102
Reason for recall
An adhesive joint in the SmartValve component of the device can become compromised resulting in a leak.
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-0105-2022
- Initiated
- August 31, 2021
- Terminated
- August 7, 2023
- Product code
- GBX – Catheter, Irrigation
- Quantity
- 310 kits
- Distribution
- Distribution to a single consignee located in California.
- Recalling firm
- Centese Inc., Omaha, NE