Recall Record

Louisville, CO, United States

ASTRA, LLC recalls

1 recall recorded since 2018, most recently on 25 April 2019. 1 is listed as ongoing. Status and classification are as published by the FDA.

Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0

Ongoing Class II Medical devices

Recall started
25 April 2019
Reason
Failure to comply event due to incorrect labeling of a class 1 laser product.
Distribution
US Nationwide Distribution
Initiated
FDA Mandated
Recall number
Z-2100-2019

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.