Recall Record

Lansing, MI, United States

Acumedia Manufacturers, Inc. recalls

2 recalls recorded since 2018, most recently on 2 August 2018. None are listed as ongoing. Status and classification are as published by the FDA.

Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0

Terminated Class III Medical devices

Recall started
2 August 2018
Terminated
18 December 2020
Reason
Expiration date on the label is incorrect. Correct expiration date was November 30, 2020 and label on distributed product listed the expiration date as November 30, 2021.
Distribution
Worldwide distribution and US nationwide in the states of CA, GA, MN, OR, RI, TX, and WY. Countries of Canada, Mexico, Scotland, and Uruguay.
Initiated
Voluntary: Firm initiated
Recall number
Z-0283-2019

Terminated Class III Medical devices

Recall started
2 August 2018
Terminated
13 January 2021
Reason
The product is labeled with an incorrect expiration date.
Distribution
US Distribution to states of: FL, TN; and internationally to countries of: Brazil, and Canada.
Initiated
Voluntary: Firm initiated
Recall number
Z-0284-2019

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.