Recall Record

Minneapolis, MN, United States

Clarus Medical, Llc recalls

1 recall recorded since 2018, most recently on 27 July 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
27 July 2021
Terminated
15 September 2022
Reason
The sterile barrier seal may be compromised.
Distribution
Distribution in US - 18 accounts 1 foreign account
Initiated
Voluntary: Firm initiated
Recall number
Z-2405-2021

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.