FDA-Device2021-10-20Class II

Thoraguard Chest Tube Kit, 20 Fr

Centese Inc.
Hazard

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

Sold states
Distribution to a single consignee located in California.
Affected count
310 kits
Manufactured in
4156 S 52nd St, N/A, Omaha, NE, United States
Products
Thoraguard Chest Tube Kit, 20 Fr

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0105-2022

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