Columbus, OH, United States
Battelle Memorial Institute recalls
1 recall recorded since 2018, most recently on 13 August 2020. 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
- 13 August 2020
- Terminated
- 3 February 2021
- Reason
- Masks processed at one site were not maintained at levels of condensation during a portion of the decontamination cycle.
- Distribution
- US Nationwide distribution including in the states of CT, MA, RI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0309-2021
- Critical Care Decontamination System (CCDS) Compatible N95 respirators - Product Usage: Used in decontaminating compatible N95 respirators2 for multiple-user3 reuse by healthcare personnel (HCP)4 to prevent exposure to
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.