Recall Record

Omaha, NE, United States

Centese Inc. recalls

1 recall recorded since 2018, most recently on 31 August 2021. None are listed as ongoing. Status and classification are as published by the FDA.

Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0

Terminated Class II Medical devices

Recall started
31 August 2021
Terminated
7 August 2023
Reason
An adhesive joint in the SmartValve component of the device can become compromised resulting in a leak.
Distribution
Distribution to a single consignee located in California.
Initiated
Voluntary: Firm initiated
Recall number
Z-0105-2022

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.