Recall Record

Strongsville, OH, United States

Nelson Innovaions, Llc recalls

1 recall recorded since 2018, most recently on 11 February 2020. 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
11 February 2020
Reason
Foreign material near or along the edge of the hydrogel adhesive within the pouch packaging
Distribution
CA, NC, PR
Initiated
Voluntary: Firm initiated
Recall number
Z-2083-2020

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.