Recall Record

Savannah, GA, United States

Brasseler USA, Medical L.L.C. recalls

1 recall recorded since 2018, most recently on 28 January 2022. 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
28 January 2022
Terminated
3 February 2023
Reason
One lot of product was distributed in unsealed packaging
Distribution
US Nationwide distribution in the states of OH, MI, AZ, FL, CA, TN, TX, SC, PA IL, ID.
Initiated
Voluntary: Firm initiated
Recall number
Z-0707-2022

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.