Home / Recalls / Centese Inc. / Z-0105-2022

Z-0105-2022 Class II Terminated

Recalled by Centese Inc. — Omaha, NE

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